Here are the job position details for your review:
Job Title: Quality Engineer (Medical & W2 Only) - NO C2C
Pay Rate: $60 to $65/Hr.
Duration: 3 Months (Potential of further extension or conversion)
Location: Newton, MA (Onsite)
Shift: 9 AM to 5 PM Eastern time
We are looking for Quality Engineer (Medical & W2 Only)
- Propose, lead, initiate, and follow up on Corrective Action and Preventive Actions (CAPA).
- Support the Internal Audit program and provide backroom support for External Audits (Regulatory, Notified Body, and Customer).
- Assist in the management of a Calibration and Preventative Maintenance program.
- Disposition of non-conforming material (NCMR).
- Support product complaint investigations leading to root cause determination.
- Support updates to the Risk Management File (FMEA, Hazard Analysis, Post Market Surveillance Reports, etc.).
- Support the completion of validation protocols and test plans (IQ, OQ, PQ, test method, and inspection method qualification).
Qualifications:
- Minimum 4-year degree in Engineering/Bio-Medical Engineering or Life Sciences (in lieu of degree additional work experience will be considered.)
- 7 to 10 years of experience as a Quality Engineer in the medical device industry; QMSR/ MDD/MDR and ISO-13485 experience required.
- Notified Body/Regulatory Audit experience; Certified Quality Auditor (CQA) certificate is preferred.
- Must have experience in CAPA, NCMR, Internal/External Audits, calibration/preventive maintenance activities, risk management activities, and design controls.
- SAP and all MS Office Suite required
Job Type: Contract
Pay: $60.00 - $65.00 per hour
Expected hours: 40 per week
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Commute:
- Auburndale, MA 02466 (Required)
Ability to Relocate:
- Auburndale, MA 02466: Relocate before starting work (Required)
Work Location: In person