Supplier Quality Engineer

Job Description -

We are seeking an experienced Senior Quality Engineer to support supplier quality activities for plastic injection-molded components used in the manufacturing of Reagent Kits. This role drives quality system compliance, risk management, validation, documentation control, and cross-functional quality initiatives. The engineer will play a key leadership role in ensuring high-quality products, processes, and supplier performance, while supporting project execution and problem-solving activities.

This position requires extensive quality engineering experience within medical device or pharmaceutical industries.

Responsibilities -

General Quality Engineering -

• Lead quality projects, define goals/milestones, and ensure on-time completion
• Provide solutions to a wide range of complex quality problems
• Ensure solutions are compliant, practical, innovative, and aligned with organizational objectives
• Lead or support cross-functional teams; serve as a quality representative on key initiatives
• Provide guidance, mentorship, and training to other QA professionals or technicians
• May oversee one or more QA professionals/contractors

Quality System Compliance -

• Maintain and support effectiveness of the Quality System
• Demonstrate strong understanding of regulatory requirements and industry standards
• Ensure compliance with site, division, and corporate quality procedures
• Address non-conformances promptly and support continuous improvement

Risk Management -

• Evaluate product safety and performance risks
• Create, analyze, and update risk management documentation
• Make independent risk-based decisions within established parameters
• Author risk control packages and ensure alignment with quality system expectations

Complaint Evaluation -

• Investigate complex product complaints with minimal oversight
• Develop compliant, thorough root-cause analyses and corrective actions
• Ensure quality and accuracy of complaint documentation

Design Control, Documentation & Change Control -

• Provide strong justification and reasoning for changes
• Identify critical parameters associated with changes
• Serve as SME or Process Community member for design and documentation-related processes

Validation -

• Act as SME for at least one validation subsystem
• Perform or review validation activities with general direction
• Ensure validation documentation meets compliance standards

Supplier Quality (Primary Focus) -

• Support supplier quality activities for injection molding (plastic) components
• Troubleshoot quality issues arising from supplier processes
• Work cross-functionally to resolve nonconformance and improve supplier performance.

Education, Qualifications & Requirements -

• Bachelor's Degree in Engineering, Life Science, or closely related discipline (required).

Experience -

• Minimum 4–10 years of Quality Engineering or related experience (less may be accepted with advanced degree)
• Required: Experience in medical device or pharmaceutical industry
• Proven history of successful project execution and strong compliance outcomes
• Background in supplier quality, injection molding, or reagent-based products preferred

Top 5 Must-Have Skills -

• Bachelor's Degree
• Nonconformance / Investigation Experience (Root Cause + CAPA)
• Validation Experience (IQ/OQ/PQ or related subsystems)
• Strong Troubleshooting & Quality Problem-Solving Skills
• Experience with Change Control & Cross-Functional Collaboration

Soft Skills -

• Strong communication and stakeholder management
• Ability to influence project direction
• Detail-oriented and compliance-driven
• Comfortable working independently with broad discretion
• Strong analytical and decision-making skills