350 Merrimack Street Remote, USA 01843
Position: Quality Engineer
Location: Remote (team in Boston, MA)
Job Type: Contract
Duration: 9 months to start
- The incumbent applies systems engineering and quality assurance principles and techniques to the product development lifecycles.
- The position will focus heavily on complaint investigation and processing activities.
- Investigate and process medical device complaints and maintain open complaint level to acceptable levels.
- Assist in maintaining quality system information databases as assigned.
- Evaluate quality data and prepare periodic reports to monitor trends.
- Assist in supporting manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
- Process non-conforming material reports including MRB dispositioning.
- Assist in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations.
- Other Quality Engineering tasks as assigned
Education & Qualifications:
- B.S. in Engineering or related field
- 0+ years related quality assurance, software quality engineering experience or an equivalent combination of experience and education.
- Medical device experience preferred.
- ASQ certification a plus.
- Beginning knowledge of FDA Quality System Regulation 21 CFR Part 820.
- Good organizational, attention to detail and follow-through skills.
- Excellent verbal communication and customer interface skills.
- Ability to interface with multiple groups in the organization.
- Basic computer skills – word processing, spreadsheet, windows.
- MS Office preferred.