Sr. Manager, Quality Systems

The Quality Systems Manager manages quality systems personnel and overseeing the Quality Management System. You will implement, support, and sustain quality system elements through procedure generation/approval, document control, training, CAPA, auditing, and technical support. In this role, you will ensure continuous compliance to external standards/regulations and internal procedures/requirements.

This position serves as a key resource of ISO, EN, MDD, MDR, J-GMP, QSR, as well as China, Korea, and MDSAP country compliance.

This role is the Designated Representative per Texas Regulations, which requires you to be onsite 100%. This is NOT a hybrid role.

Responsibilities:

• Plan and manage the development and execution of quality process improvement activities to strengthen the site’s quality system, conform to quality objectives, and utilize risk-based decision making.
• Prepare and deliver quality systems metrics for management review meetings.
• Supervise document control activities to ensure compliance with policies and procedures as well as timely and accurate processing of changes and documents. Manage the record retention program for quality documentation.
• Oversee the CAPA program to ensure the robustness of CAPA initiation, investigations, corrections, and corrective/preventive actions.
• Coordinate and support training for personnel within the Austin QMS. Ensure training requirements are identified and assigned appropriately. Monitor the adequacy and effectiveness of the training program.
• Manage the preparation, coordination, execution and documentation of internal and external audits. Author audit responses and maintain tracking systems/processes to ensure commitments are met on time.
• Establish and maintain successful cross-functional relationships with R&D, engineering, manufacturing, marketing, quality and regulatory affairs departments.
• Act as the Quality Management Representative during the absence of the site quality director. Act as the back-up Person Responsible for Regulatory Compliance. Serve as the primary Designated Representative for the Austin, TX site.

Education:

• Bachelor’s degree preferred, or relevant experience

Licenses/Certifiations:

• License/certification: Preferred CQE/CRE, ISO 13485 lead auditor certification
• Competencies: risk-based decision making, excellent oral and written communication, strong leadership skills to develop, coach, and inspire team members.

Location: Austin, TX, 100% onsite (relocation assistance is available)

Experience:

• 8+ years in a quality assurance environment, medical device or pharmaceuticals preferred,
• 2+ years supervisory/management experience.

At Smith+Nephew, we offer competitive and rewarding compensation and benefits packages!

Our benefits packages vary from country to country and by level, but often the total package includes the following:

• A competitive salary with an annual bonus plan.
• Strong Healthcare coverage.
• A competitive company retirement benefit scheme for all employees.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job Type: Full-time

Pay: $140,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Schedule:

• Day shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Austin, TX 78735: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Application Question(s):

• This role is a 100% Onsite role, would you be willing to work completely on-site for this position?

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 6 years (Required)
• supervisory/management: 2 years (Required)

Work Location: In person