Quality Engineer II
Spectraforce
Marlborough, Massachusetts
a month ago
Job Description
Position Title: Quality Engineer II
Work Location: 445 Simarano Drive, Marlborough, MA 01752
Assignment Duration: 6 Months
Work Schedule: 8:30 AM–5:00 PM
Position Summary: Role supports a Test Method Validation (TMV) remediation initiative. Primary need is a seasoned QE with strong, hands-on TMV experience.
Background & Context: Role is part of a remediation initiative.
Key Responsibilities:
- Heavy focus on execution of test method validation, not just documentation
- Candidate will lead TMV efforts with support from existing Quality Engineers
- Work involves interaction with engineering teams and execution of testing
- Past candidates lacked true hands-on TMV knowledge despite resume claims
- Strong communication skills and technical depth are critical
- Onsite role with standard hours of 8:30 AM–5:00 PM
Qualification & Experience:
- Bachelor’s degree in Engineering, Quality, or related technical field
- 5–7 years of hands-on Test Method Validation experience preferred
- Strong understanding of validation processes and execution
- Experience validating test methods used in instruments or manufacturing environments
- Familiarity with ISO 13485 quality systems
- Understanding of risk management concepts (ISO 14971), PFMEAs, and MSA is a plus
- Ability to interact cross-functionally with engineering and quality teams
- Strong technical communication and problem-solving skills
- Medical device or instrument manufacturing background strongly preferred
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 44.00/hr.