Senior Quality Engineer

Requirements

• This individual will be responsible for supporting the Product Lifecycle, Design Control, and Design Transfer processes, as well as the quality elements of design projects
• Provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles
• Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations
• Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.)
• Lead test method validation activities and Gage R&R studies for Combination Product
• Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, Design Verification & Validation, Process Characterization & Validation, Component Qualification
• Identify quality characteristics and validation criteria for components, subassemblies, and finished product
• Work with R&D in the creation of requirements for new products and engineering specifications
• Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971
• Provides direction to Engineering to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards within the area of Design Controls
• Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
• Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports
• Support quality assurance activities, including, but not limited to: internal and external audits, NCMRs and CAPAs,
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
• Other duties/ activities may be necessary to support departmental or company goals

Education and/or Job Experience

• A minimum of 8 years quality assurance/engineering in a regulated industry (medical device,) is required
• BS degree in Mechanical Engineering or related field is required
• Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485
• Experience with Risk Management process (Risk Management Plan/Report, FMEA's) and associated standards (ISO 14971:2019)
• Understanding of multiple technology areas (software, mechanical, electrical, biomedical, test automation, etc.)
• Must be a self-starter and capable of working independently and within a team.
• Experience performing statistical analysis (Six Sigma preferred)
• CQE, CQA preferred

Skills and Specifications

• Ability to motivate and influence people
• Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
• Ability to create and provide training
• Good statistical and numerical ability
• Exceptional problem-solving skills
• Understands and can subsequently explain complex quality details to non-experts