Quality Engineer II

Support medical device quality engineering activities across the product lifecycle, including risk management, design changes, post-market quality, investigations, and technical documentation for surgical stapling products.

Job Requirements

• Bachelor’s degree in Engineering.
• 2–4 years of experience in the medical device industry.
• Experience performing product and process risk assessments.
• Experience supporting design changes and engineering change reviews.
• Experience with post-market quality activities.
• Experience developing and maintaining Design Failure Mode and Effects Analysis (DFMEA).
• Experience with technical writing and controlled engineering documentation.
• Experience performing data analysis related to product quality and reliability.
• Experience with project management or technical project leadership.
• Knowledge of medical device product lifecycle activities, including design, manufacturing, distribution, and obsolescence.

Preferred Skills

• Experience supporting surgical devices or surgical stapling products.
• Experience reviewing and maintaining risk management files.
• Experience conducting root cause investigations.
• Experience supporting released product quality issues.
• Experience with product reliability assessments.
• Experience supporting continuous improvement and product/process change initiatives.

Job Responsibilities

• Perform and support product and process risk assessments.
• Review and approve quality documentation associated with design and engineering changes.
• Develop, update, and maintain DFMEAs and related technical documentation.
• Support post-market quality activities for released medical device products.
• Investigate product quality issues and perform root cause analysis.
• Review product design information to identify and assess potential risks.
• Review and maintain risk management documentation throughout the product lifecycle.
• Perform product quality assessments and analyze quality and reliability data.
• Support product and process changes required to address market and manufacturing requirements.
• Participate in continuous improvement projects involving product quality, reliability, and manufacturing processes.
• Evaluate engineering changes for compliance with applicable quality requirements.
• Support quality activities across design, manufacturing, distribution, and product obsolescence.
• Lead or coordinate quality engineering projects involving cross-functional engineering and manufacturing activities.

Pay Details: $40.00 to $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.