Director Quality Engineer Fda Jobs (NOW HIRING)

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

As a key member of the Quality team, the Senior Director Quality will be responsible for developing, implementing, and continuously improving the organization's Product Quality and Production Quality programs across the medical device lifecycle. This position ensures compliance with global regulatory requirements, quality management system (QMS) standards, and company objectives while driving a culture of quality, operational excellence, and patient safety. The role provides leadership for product quality assurance, manufacturing quality, supplier quality, risk management, and continuous improvement initiatives.

About the Role:

Quality Leadership & Strategy

• Develop and execute the quality strategy aligned with corporate goals and regulatory requirements.
• Lead and mentor Product and Manufacturing Quality teams across multiple sites and/or regions.
• Establish quality objectives, key performance indicators (KPIs), and continuous improvement plans.
• Drive a culture of quality, compliance, customer focus, and operational excellence throughout the organization.

Product Quality Management

• Oversee product quality throughout design transfer, manufacturing, commercialization, and post-market activities.
• Ensure robust quality oversight of design changes, process changes, and product lifecycle management activities.
• Lead investigations and resolution of product quality issues, nonconformances, customer complaints, and field actions.
• Ensure effective implementation of risk management processes consistent with ISO 14971 requirements.
• Monitor and analyze quality data, complaint trends, field performance, and reliability metrics to drive product improvements.
• Partner with R&D and Regulatory Affairs to support product development and design validation activities.

Production & Manufacturing Quality

• Provide leadership for manufacturing quality systems, including incoming inspection, in-process controls, final release, and quality engineering.
• Ensure effective control of manufacturing processes, validation activities, and process monitoring systems.
• Lead quality oversight of production operations to ensure compliance with FDA Quality System Regulation (QSR), ISO 13485, and other applicable standards.
• Drive reduction of scrap, rework, defects, and manufacturing nonconformances through data-driven quality initiatives.
• Support operational excellence and Lean/Six Sigma programs to improve efficiency and product quality.

Regulatory & Compliance Support

• Act as a primary quality representative during FDA inspections, notified body audits, and customer audits in conjunction with other Quality leadership.
• Ensure timely responses to audit observations and regulatory findings, particularly as they relate to products and manufacturing.
• Support regulatory submissions and product approvals as required.

Continuous Improvement

• Utilize quality metrics, statistical techniques, and quality engineering tools to improve product and process performance.
• Lead root cause investigations and implementation of effective corrective and preventive actions.
• Promote use of Lean, Six Sigma, and risk-based approaches throughout quality and manufacturing operations.
• Identify opportunities for automation, process simplification, and digital quality transformation.

Leadership Responsibilities

• Lead, coach, and develop quality management professionals and technical teams.
• Build organizational capabilities through talent development and succession planning.
• Foster cross-functional collaboration and accountability.
• Manage departmental budgets, resource planning, and organizational priorities.

Minimum Qualifications:

• Bachelor's degree in Engineering, Quality, Life Sciences, Biomedical Engineering, or related discipline required.
• 12+ years of progressive quality leadership experience within the medical device industry.
• Minimum 5–7 years of leadership experience managing quality organizations. 
• Demonstrated experience with Product Quality, Manufacturing Quality, Quality Engineering, CAPA and investigation systems, FDA inspections and global regulatory audits, ISO 13485 and medical device regulations.

Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification.
• Experience supporting Class II and/or Class III medical devices.
• Multi-site and global quality management experience.

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries. 

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events
• Awarded 2024 Cigna Healthy Workforce Designation Gold Level

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.