Associate Manager, Quality Assurance

Stryker is seeking an Associate Manager, Quality Assurance to provide first-line leadership for a team supporting Product Transfer, Validation, and Continuous Improvement initiatives. This role is responsible for building team capability, driving operational excellence, ensuring compliance with regulatory and quality system requirements, and delivering successful validation and product transfer programs that support business growth and product lifecycle management.

The Associate Manager will lead a team of engineers and quality professionals while partnering closely with Operations, Engineering, Product Transfer (PT), Supply Chain, and other Quality functions to ensure consistent execution, effective risk management, and predictable delivery of business objectives. The team will also play a key role in supporting Continuous Improvement projects that strengthen organizational capability, scalability, and operational performance.

• Provide first-line leadership and operational direction to a team of engineers and quality professionals.
• Build team capability and engagement through coaching, mentoring, performance management, and development planning.
• Foster a culture of accountability, collaboration, continuous improvement, and quality excellence.
• Develop future leaders and technical subject matter experts, creating a strong succession pipeline.
• Establish clear performance expectations, priorities, and objectives that align with organizational goals.

• Lead and support product transfer and validation activities, including process validation, equipment qualification (IQ/OQ/PQ), cleaning validation, computerized systems validation, and manufacturing process transfers.
• Develop, review, and approve Validation Master Plans, protocols, reports, risk assessments, and lifecycle documentation.
• Ensure validation strategies comply with FDA, ISO 13485, EU MDR, and applicable corporate requirements.
• Drive execution of validation programs supporting new product introductions, capacity expansion, and manufacturing process changes.

• Own quality outcomes within the assigned area, including deviations, investigations, CAPAs, and quality system improvements.
• Make and approve routine quality decisions while balancing compliance, delivery, and business needs.
• Support internal audits, supplier audits, customer audits, and regulatory inspections as required.
• Ensure timely implementation and effectiveness of corrective and preventive actions.
• Drive continuous improvement initiatives that enhance compliance, efficiency, and quality system performance.
• Promote a proactive quality culture focused on prevention rather than correction.

• Partner effectively with Operations, Engineering, AO, PT, R&D, Regulatory Affairs, Supply Chain, and Quality teams to achieve project and business objectives.
• Serve as a trusted and reliable cross-functional partner for technical and quality-related decision making.
• Communicate effectively with stakeholders at all levels, ensuring alignment on priorities, risks, timelines, and deliverables.

• Bachelor's Degree or Master's Degree in Engineering, Science, Quality, Manufacturing, or a related discipline.
• Minimum 6+ years of professional experience within the medical device, pharmaceutical, biotechnology, or other regulated manufacturing industries.
• Experience supporting validation activities, including process validation, equipment qualification, cleaning validation, computerized systems validation, and product transfer programs.
• Strong understanding of quality systems, regulatory requirements, risk management, CAPA, deviations, and investigations.
• Demonstrated ability to drive quality improvements and operational execution through data-driven decision-making.
• Proven ability to collaborate effectively across multiple functions and manage competing priorities in a dynamic environment.

Salary information will be provided during the recruitment process.