Senior Quality Engineer

Who you are

• The ideal candidate brings strong technical problem-solving skills, sound quality judgment, and a collaborative, hands-on approach to identifying root causes and driving sustainable improvements
• 5+ years of Quality Engineering or Sustaining Engineering experience within the medical device industry, preferably supporting commercial electromechanical products
• Demonstrated experience with post-market and sustaining quality activities, including nonconformances, CAPAs, change control, root cause investigations, and verification and validation
• Working knowledge of ISO 13485, FDA Quality System requirements, ISO 14971, and IEC 60601-1
• Experience applying risk management principles throughout the commercial product lifecycle
• Strong technical problem-solving and root cause analysis skills
• Bachelor’s degree in Engineering, Science, or a related technical discipline; Master’s degree is a plus
• Ability to work effectively across Engineering, Manufacturing, Operations, Supplier Quality, and other cross-functional teams
• Strong organizational skills with the ability to manage multiple priorities and consistently complete work on schedule
• Excellent written and verbal communication skills

What the job involves

• Element Science is seeking a Sr. Quality Engineer to support the ongoing quality, reliability, and continuous improvement of our life-saving medical device technology
• This role provides Quality Engineering support across the commercial product life cycle and leads the supplier quality program
• It partners closely with Engineering, Manufacturing, Supplier Quality, Operations, Supply Chain and other cross-functional teams to ensure products and purchased components continue to meet quality, safety, performance, and regulatory requirements throughout the commercial product lifecycle
• The Sr. Quality Engineer will provide Quality Engineering support for product and process changes, nonconformances, CAPAs, complaints, supplier qualification and performance, risk management, and verification and validation activities
• This role will partner with manufacturing on process capability and provide Quality oversight and approval to those activities
• Serve as the Quality Engineering partner for sustaining engineering and post-market product activities, ensuring continued compliance with applicable quality and regulatory requirements
• Provide Quality oversight for product, component, manufacturing, supplier, and design changes, including assessment of verification and validation requirements
• Support nonconformance, complaint investigation and CAPA activities, including root cause analysis, risk assessment, corrective actions, and effectiveness verification
• Partner with Engineering and Operations to investigate product and manufacturing issues and implement sustainable corrective and preventive solutions
• Maintain and update Risk Management Files in accordance with ISO 14971, incorporating post-market information, product changes, complaints, and identified risks
• Analyze quality and product performance metrics to identify trends and drive systemic quality and reliability improvements
• Provide technical Quality expertise for electrical and electromechanical product issues and changes
• Responsible for supplier quality programs including supplier evaluation, selection, qualification, re-qualification and maintenance of the Approved Supplier List (ASL)
• Plan and perform onsite and remote supplier audits to assess compliance with ISO 13485, regulatory standards, and internal requirements
• Establish and maintain supplier quality agreements
• Monitor supplier quality performance through scorecards and periodic quality reviews, including Supplier Corrective Action Requests (SCARs) and drive them to closure
• Define incoming inspection requirements, sampling plans, and first article inspection for purchased components. Lead disposition of supplier-related nonconformances through MRB
• Review supplier process capability and validation evidence for critical-to-quality characteristics during supplier qualification and change approval
• Lead supplier quality improvement initiatives
• Partner with Manufacturing Engineering on process characterization, process capability (Cpk/Ppk), SPC, pFMEA, and process and equipment validation (IQ/OQ/PQ). Review and approve protocols and reports ensuring acceptance criteria are risk-based and statistically justified
• Develop and execute verification and validation plans, protocols, and reports for sustaining activities, including test method validation for inspection and test methods, as applicable
• Support continuous improvement of Quality System procedures, Standard Operating Procedures, and Work Instructions
• Mentor junior engineers and Quality team members, and promote strong Quality Engineering practices across cross-functional teams
• Perform other responsibilities as assigned

Benefits

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO