Senior Quality Engineer

SUMMARY OF ROLE:

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.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.

RESPONSIBILITIES:

Sustaining Quality

• 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.

Supplier Quality

• 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.

Manufacturing & Process Quality Oversight

• 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.

Quality System & Leadership

• 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.

QUALIFICATIONS:

• 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.

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

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

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $165,000 - $177,000