Senior Quality Engineer

Work Schedule: Hybrid, 4 days/week onsite

We are seeking a Senior Quality Engineer to provide Quality Engineering support across design transfer, inspection, production, and data monitoring activities. This role will lead quality initiatives and projects, support process and equipment qualification, and ensure compliance with established procedures.

The Senior Quality Engineer will work closely with R&D, Manufacturing Engineering, and cross-functional teams to resolve quality issues, strengthen Quality Systems, and drive continuous improvement. This position will also communicate with site leadership and influence quality and compliance initiatives across the organization.

• Provide expertise and oversight for the management and improvement of Quality Systems, including quality planning, quality control planning, internal auditing, inspection procedures, document control, change management, process controls, quality records, CAPA, validation, and data management.
• Develop plans to resolve quality issues and use analytical and communication skills to support effective solutions and process changes.
• Communicate with leadership regarding quality risks, solutions, and business considerations.
• Mentor and support Quality Engineers.
• Make confident, risk-based quality decisions.
• Prepare and review Engineering Change Orders (ECOs) and Manufacturing Variances (MVs).
• Design and validate queries and reports using production, nonconforming material, and CAPA data.
• Participate in or lead Product Line Quality Committees (PLQCs).
• Develop, format, manage, and maintain Quality Control Plans and PFMEAs for new products.
• Review specifications related to acceptance activities.
• Support Quality Plan activities for company projects.
• Analyze quality data, identify trends, and generate reports and conclusions.
• Generate and review validation protocols and reports, including IQ, OQ, and PQ.
• Participate in external audits and communicate directly with auditors when appropriate.
• Ensure validation activities meet applicable requirements and internal procedures.
• Maintain validation files, logs, and validated spreadsheet documentation.
• Lead problem-solving activities to determine root causes and implement effective corrective actions.
• Support the Quality Management Review process by gathering and analyzing relevant information.
• Assist leadership with improving Quality Systems and increasing compliance with applicable regulations.
• Proactively identify Quality System gaps and develop solutions to close them.

• Bachelor's degree or higher in Engineering, Science, or a related technical discipline.
• 7+ years of Medical Device or IVD Quality Engineering experience
  , or 4+ years of Senior Quality Engineering experience within an FDA-regulated medical device, IVD, reagent, or similar manufacturing environment.
• Strong knowledge of regulations and standards applicable to medical devices and IVDs, including:
• ISO 9001
• ISO 13485
• ISO 14971
• IVDR
• FDA requirements
• Experience working in an FDA-regulated manufacturing environment.
• Strong oral and written communication skills.
• Excellent organization, prioritization, and multitasking abilities.
• Strong attention to detail with the ability to interpret technical documentation.
• Ability to collaborate effectively with multidisciplinary teams.
• Sound judgment in selecting appropriate methods and techniques to achieve results.
• Proficiency with Microsoft Word and Excel;
  Microsoft Access experience is beneficial.
• Experience with statistical analysis software such as Minitab
  .

• Experience with Master Control
  .
• Experience with Power BI
  .
• Internal or external auditing experience.
• Quality auditing certification.

• Ability to stand or sit for extended periods.
• Manual dexterity for handling laboratory equipment and instrumentation.
• Ability to lift and carry up to 25 pounds.
• Ability to perform repetitive tasks.
• Comfortable working in a laboratory environment with potential exposure to chemicals or biological materials.
• Ability to properly use required personal protective equipment (PPE).
• Occasional bending, reaching, and movement within a laboratory environment.
• Medical, dental, and vision coverage
• 401(k) with company match
• Generous paid time off and paid holidays
• Hybrid and flexible work arrangements
• Employee engagement programs and events
• On-site lunch and snack programs
• Subsidized cafeteria at select locations