Sr Quality Engineer

Responsible for design and development quality support, risk management, and technical documentation for medical device projects.

Required Qualifications

• Green Belt Six Sigma or DRM Training/Certification

• ASQ-CQE, CQA, CBA, or equivalent certifications

• Experience with SAP QM or SPC software

• Working knowledge of QSR (21 CFR 820), CMDR, EU MDD (93/42 EEC), JPAL, and ISO 13485:2016

• Demonstrated knowledge of process validation, statistical methods, and risk management (dFMEA, pFMEA, statistical analysis)

Preferred Skills

• Experience in medical device design and development

• Proficiency in risk management methodologies and statistical tools

• Strong background in technical writing including IQs, PQs, and TMVs

Responsibilities

• Support medical device design and development activities through quality oversight

• Conduct and maintain risk management activities including dFMEA and pFMEA

• Perform statistical analysis to support validation and process improvement

• Prepare technical documentation including IQs, PQs, and TMVs

• Ensure compliance with global medical device regulations and standards

• Apply Six Sigma and quality engineering principles to process and product improvements

• Collaborate with cross-functional teams to integrate quality requirements into design and production

Pay Details: $50.00 to $60.00 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

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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.