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Quality Engineer, Biotechnology

Company Description

Every minute of every day, Smiths Detection’s threat detection and security screening technology helps to protect people and infrastructure, making the world a safer place. 

Smiths Detection, part of Smiths Group is a global leader in the development, manufacture and management of security and detection solutions designed to make the world a safer place. Our technology provides threat detection and screening solutions for customers in our key markets: aviation, ports and borders, defence, and urban security.

Our expertise spans 21 global offices, seven manufacturing sites and five R&D centres, with a global network of 3,000 dedicated colleagues contributing towards over 40 years at the frontline of advances in safety and security.  

This results in careers built on variety and the opportunity to work on a range of state-of-the-art solutions, where you can develop your knowledge and experience every day.

Job Description

As a Quality Engineer- Biotechnology you are responsible for product quality on assigned programs to ensure that customer contract requirements are fulfilled. You will routinely liaise with internal Engineering, Sales, Supply Chain, and Operations departments as well as Field Service. The Quality Engineer may also interface with customers and potential suppliers. You'll be part of an organization expected to perform by setting an example to the rest of the business.

  • Work cross functionally with Science and Technology, Manufacturing Engineering and Production in providing effective and responsive support to resolve in-house, customer and supplier quality related issues.
  • Perform Corrective and Preventive action management with root cause analysis in order to safeguard the product and the customer experience.
  • Assist in the development, implementation and maintenance of the QMS to ISO9001 including completion of Internal Audits and development of internal processes/procedures.
  • Perform in-process and final assembly inspections, collect and publish results, and conduct feedback sessions for corrective and preventative action.
  • Support the engineering and manufacturing teams to help design and execute the necessary product qualification and validation tests and any necessary analysis and follow-up activities.
  • Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of Production Part Approval Process (PPAP) activities.
  • Conduct product performance analysis and reporting.
  • Drive and implement quality system improvements in alignment with and/or under the direction of the Quality Manager.
  • Participate in problem solving meetings using approved/formal problem-solving tools (8D, PDCA, etc).
  • Perform PFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
  • Maintain 5S practices. Participate / facilitate in LEAN 6 Sigma events.
  • Support key quality and management system processes such as NCR, CAPA and ECN.
  • Lead training activities on Quality related procedures.
  • Provide functional expertise to other support functions on quality related issues.

Qualifications

Education:

  • Bachelor’s Degree in Engineering, Manufacturing, or related field
  • Significant experience in lieu of a degree considered
  • ASQ Certified Quality Engineer preferred

Experience: 

  • 5 years of experience required in a manufacturing environment
  • Quality engineering experience in an ISO-9001 environment required
  • Experience in First Article Inspection (FAI) required
  • Experience working in a union environment preferred

Knowledge/skills:

  • Familiar with typical ERP business system software (SAP preferred)
  • Proficient in MS Office products including Excel, PowerPoint, and Word and other CRM tools
  • Excellent written and oral communication skills 
  • Ability to multi-task and prioritize, be a self-starter, results oriented team player
  • Strong attention to detail and accuracy
  • Ability to work independently
  • Strong interpersonal and networking skills with ability to interface, influence and lead the organization, employees and customers at all levels
  • Driving Results – The ability and motivation to persistently pursue and achieve effective results which drive business forward
  • Collaboration & Influencing – the ability to engage, challenge and work effectively with others
  • Driving Change – Willing and able to identify and support change and continuous improvement

Background:

This position may require Sensitive Security Information (SSI) access and vetting via the TSA. If required, applicant must successfully pass a federal background investigation. This position may require a U.S. Personal Security Clearance.

SDI is a Federal Contractor and a drug-free workplace. By submitting an application, I confirm that I understand that the Company has a right to require me to submit to a drug test prior to employment and at any time during my employment, to the extent permitted by law.

WORK ENVIRONMENT: The individual’s primary workplace is located in the Baltimore, MD biotechnology manufacturing facility; there are no exposures to unusual elements; possible exposure to biohazardous agents in BSL-2 laboratory

Additional Information

We offer…

Join us and we’ll help build your career, with excellent training and opportunities for career growth across the business, both locally and globally. You’ll experience an inclusive environment, with strong leadership and a focus on safety and wellbeing. You’ll also have the flexibility to choose from a wide range of benefits to suit your lifestyle, offering you and your family support from a health and wellbeing, financial and lifestyle perspective.

Join us and work for a world-leader, with the benefits and training to reward your dedication and skills. Be part of a team where we are making the world a safer place.

Smiths Detection is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters  If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email [email protected].

The compensation for this position ranges from $45,760.00 - $155,200.00/yr and will vary depending on factors such as your location, skills, job-related knowledge, and experience. The compensation package may also include incentive compensation opportunities in the form of discretionary annual bonus or commissions. Smiths Detection provides comprehensive benefits including healthcare, 401K savings plan, company holidays, vacation, sick time, parental leave and an employee assistance program. Eligibility requirements apply.

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail [email protected] or call toll-free 877-703-1029. This email and phone number is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. Smiths Detection, Inc. participates in the Electronic Employment Verification Program.

We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, colour, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.

At no time during the hiring process will Smiths Group, nor any of our recruitment partners ever request payment to enable participation – including, but not limited to, interviews or testing. Avoid fraudulent requests by applying jobs directly through our career’s website (Careers - Smiths Group plc)

Average salary estimate

$100480 / YEARLY (est.)
min
max
$45760K
$155200K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Quality Engineer, Biotechnology, Smiths Group

Are you ready to take your career to the next level as a Quality Engineer in the Biotechnology sector? At Smiths Detection, located in the heart of Baltimore, MD, we are at the forefront of safety and security, developing technologies that protect people and infrastructure worldwide. As a Quality Engineer, you'll be the guardian of product quality for assigned programs, ensuring that our customers' contract requirements are met to the highest standards. Your role will involve collaborating with various internal teams, including Engineering, Sales, and Manufacturing, as well as liaising with customers and suppliers. You'll have the opportunity to conduct inspections, manage corrective actions, and support product qualifications, all while enhancing our Quality Management System to ISO9001 standards. If you have a strong engineering background, preferably with Quality Engineering experience in manufacturing, and possess excellent communication skills, we want to hear from you! Here, you’ll not only help ensure product excellence but also be part of a dynamic team dedicated to making the world a safer place. Join us and see how your contributions can positively impact safety and security across the globe, all while enjoying great benefits and opportunities for growth.

Frequently Asked Questions (FAQs) for Quality Engineer, Biotechnology Role at Smiths Group
What are the responsibilities of a Quality Engineer at Smiths Detection?

As a Quality Engineer at Smiths Detection, your primary responsibilities include ensuring product quality across assigned programs, collaborating with internal teams to manage quality-related issues, conducting inspections, and implementing corrective actions and preventive measures. You will also assist with the development and maintenance of the Quality Management System to ISO9001 standards.

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What qualifications do you need to apply for the Quality Engineer position at Smiths Detection?

To apply for the Quality Engineer position at Smiths Detection, candidates should typically have a Bachelor's Degree in Engineering, Manufacturing, or a related field. While a degree is preferred, significant experience in a relevant role may be considered. Additionally, having 5 years of experience in a manufacturing environment and familiarity with ISO-9001 standards is crucial.

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What kind of work environment can a Quality Engineer expect at Smiths Detection?

A Quality Engineer at Smiths Detection will primarily work in a Baltimore biotechnology manufacturing facility. The work environment is standard for a manufacturing setup with safety protocols in place, and employees might have occasional exposure to biohazardous agents in a BSL-2 laboratory setting.

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Is certification necessary for the Quality Engineer role at Smiths Detection?

While not mandatory, certification as an ASQ Certified Quality Engineer is preferred for the Quality Engineer role at Smiths Detection. Such certifications can enhance your candidacy and show your commitment to maintaining quality and safety standards.

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What opportunities for career growth does Smiths Detection offer to Quality Engineers?

Smiths Detection is committed to supporting career development for its employees. As a Quality Engineer, you will have access to extensive training programs and opportunities for advancement within the company. With a focus on inclusive growth, the company encourages employees to develop their skills and pursue new roles as they progress in their careers.

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Common Interview Questions for Quality Engineer, Biotechnology
Can you describe your experience with ISO9001 standards as a Quality Engineer?

In your response, highlight specific experience with ISO9001 implementation and auditing processes. Discuss how you've contributed to maintaining compliance and any corrective actions you've managed.

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How do you handle quality-related issues that arise during production?

Explain your problem-solving process, emphasizing the use of root cause analysis and the steps you take to implement corrective and preventive measures to ensure long-term solutions.

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What tools do you find most effective for conducting product inspections?

Share specific inspection tools, methodologies, and software that you've used in your previous roles. Discuss how they enhance accuracy and efficiency in quality control.

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How do you prioritize multiple projects and tasks within a quality engineering role?

Describe your approach to managing time and tasks, including how you assess priorities based on project deadlines, regulatory requirements, and potential impact on product quality.

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Can you give an example of a successful CAPA you managed?

Outline a specific situation where you led a Corrective and Preventive Action process, the actions taken, and the positive outcomes resulting from your involvement and follow-ups.

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What is your experience with cross-functional collaboration?

Discuss how you've worked with other teams, such as Engineering and Production, to address quality issues and ensure product excellence. Provide examples of successful collaborations.

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What quality improvement methodologies are you familiar with?

Mention methodologies like Six Sigma, Lean Manufacturing, and PDCA, and how you've applied them in your previous roles to drive quality improvements.

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How would you explain a technical quality issue to a non-technical stakeholder?

Describe your approach to simplifying complex information, using analogies or examples that relate to the stakeholder's area of expertise to ensure clear understanding.

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What steps do you take to ensure continuous improvement in the production process?

Talk about your strategies for regular review and assessment of processes, how you engage the team in improvement initiatives, and examples of changes that led to better efficiency or quality.

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Why do you want to work as a Quality Engineer at Smiths Detection?

Express your passion for contributing to safety and security technologies and how your skills align with Smiths Detection’s mission. Speak on the values of the company and what excites you about the role.

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Founded in 1851 and headquartered in London, United Kingdom, Smiths Group is a multinational technology company serving the medical technology, security and defense, industrial, energy, and aerospace markets.

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Full-time, on-site
DATE POSTED
December 11, 2024

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