Senior Manufacturing Quality Engineer

Senior Manufacturing Quality Engineer

The Senior Manufacturing Quality Engineer will work cross functionally with manufacturing teams to drive continuous improvement initiatives. This role is responsible for designing and configuring automated measurement systems. The engineer will serve as a subject matter expert in inspection and test methods, providing daily quality control (QC) support. Responsibilities include implementing automated measurement systems, establishing process monitoring, and leading investigations to reduce scrap, while ensuring adherence to change control requirements.

Additional responsibilities include authoring and managing documentation related to test method validation, measurement system analysis, inspection procedures, and risk analysis. Supporting production by troubleshooting issues and improving yields, collaborating with contract manufacturers to resolve issues, closing non-conforming material reports promptly, and ensuring adherence to internal procedures are crucial. Lead the analysis of complaint investigations and ensure compliance with quality management systems and regulatory requirements.

Additionally, assisting in conducting internal audits, maintaining up-to-date technical knowledge, and supervising and mentoring production inspectors are important duties.

Essential duties and responsibilities include, but are not limited to, the following:

• Design, configure, implement and maintain automated measurement systems. Includes creation of inspection tooling fixtures.
• Develop and execute test methods validation, measurement system analysis protocols and process validation. Generate complex technical written reports, including statistical analysis to justify sample size selection, equivalence, and acceptable error rates.
• Author and manage documentation related to test methods, inspection training and procedures.
• Deploy process monitoring systems and maintain statistical process control (SPC) practices.
• Support production by troubleshooting issues, improving yields, and collaborating with contract manufacturers to resolve quality issues. Ensure timely closure of non-conforming material reports (NCRs) and adherence to internal procedures.
• Serve as subject matter expert (SME) for inspection methods for devices manufacturing and purchased components.
• Mentor and train inspector technicians to automated inspection systems and inspection good practices aligned with ISO/IEC 17025 principles.
• Review and approve Quality Engineering assessments for Document Change Orders (DCOs) and Supplier Change Notices (SCNs).
• Define and implement quality improvement projects for E  and supplier's manufacturing processes. Work with various departments to ensure timely closure of CAPAs, NCRs, and complaints.
• Coordinate cross-functionally to release or place materials on hold when segregated as non-conforming. Document nonconformances, including root cause analysis and corrective actions.
• Support the supplier quality management program through supplier monitoring, audits and issues resolution, including supplier corrective action requests (SCARs), operations NCRs and audit findings.
• Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost. Proactively solve moderately complex problems at the product level.
• Assist with risk analysis activities and maintaining up to date risk management documents.
• Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/EU MDR regulations. Adhere to established company Quality System procedures, the Quality Policy, and work instructions.

Other duties and responsibilities:

• Maintain state of the art technical knowledge.
• Other duties as assigned.

Education and required experience:

• BS in Mechanical engineer or biomedical engineering.
• Four years of related medical device experience.
• Can be an equivalent combination of education and professional experience.

Knowledge, skills, and abilities:

• Your understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and EU MDR will enable you to properly audit and monitor suppliers.
• Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.
• Proficiency with software, such as Mini Tab, Solidworks, Master Control preferred.
• Ability to work independently, using good judgment, initiative, and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
• Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.
• Self-motivated and self-directed; conscientious approach to work assignments.

Physical requirements:

• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific…