One of our clients is looking for a talented and highly motivated Quality Engineer 4. Please send your resume if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.
Here are the job position details for your review:
Job Title: Quality Engineer 4
Pay Rate: $60 to $65/HR
Duration: 3 months
Location: Newton, MA
Shift: 9 AM - 5 PM
This position is for the Healthcare Diagnostics division.
We are looking for Quality Engineer 4
- Interface with all departments in the organization in matters related to quality system compliance.
- 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.).
- Review and as needed update QMS procedures (SOPs, Work Instructions, Forms) to reflect the latest industry standards, guidance documents, and best practices.
- Support the completion of validation protocols and test plans (IQ, OQ, PQ, test method, and inspection method qualification).
- As appropriate, assist in supplier qualification activities (initial assessments and categorization).
- Other duties as assigned by the manager.
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.
- Technical skills including the ability to read technical specifications and interpret industry standards and regulations.
- Effective and professional communication skills; Internal (engineering, operations, R&D, etc.) and external (customers, auditors, and suppliers) required.
- Effective time/task management skills; Excel working in a fast-paced environment.
Job Type: Contract
Pay: $60.00 - $65.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Application Question(s):
- This is a W2 position, Are you ok work on W2?
- Please provide your email address
Education:
Experience:
- Quality Engineering: 4 years (Required)
- Corrective & Prevetnive Action/Non Conforamnce/NCRs/NCMR: 4 years (Required)
- QMSR/ MDD/MDR: 4 years (Required)
- Medical Device/Biomedical industry: 4 years (Required)
Ability to Commute:
- Newton, MA 02458 (Required)
Work Location: In person