Adecco is hiring for a Sr Quality Engineer for a manufacturer in Devens! This is a direct hire position.
Salary range:
$100,000 - $120,000 annually
Key Responsibilities Design Controls & Risk:
Oversee Design History Files (DHF), design verifications, and risk management files per
ISO 14971.
Process Validation:
Lead and approve
IQ/OQ/PQ
manufacturing validations, test methods, and statistical analysis (SPC, DOE).
Quality Operations:
Manage non-conformances (NCR), Corrective and Preventive Actions (CAPA), and failure investigations.
Cross-Functional Leadership:
Partner with R&D, manufacturing, and regulatory teams during new product introduction (NPI) and product changes.
Auditing & Compliance:
Support internal and external audits, ensuring adherence to
FDA 21 CFR
Part 820 regulations.
Qualifications & Requirements Education:
Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering, or a related technical discipline (Master's preferred).
Experience:
5-8+ years of medical device or regulated industry experience.
Core Knowledge:
Deep familiarity with FDA Quality System Regulations (QSR), ISO 13485, and
ISO 14971.
Pay Details:
$100,000.00 to $120,000.00 per year 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 To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy 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.
