SR Quality Engineer
Profile
- $100,000 - $115,000 annual
- Health Insurance
- Executive
- Quality Assurance
- Quality Control
- Permanent position
- 36h-40h
The successful candidate will be a highly valued member of the Cardiac Care business within our client's organization. The position will be located in Andover, MA.
Job Description
- Conduct product and process Corrective and Preventive Action (CAPA) investigations from issue identification through to implementation of solution and affectivity monitoring.
- Conduct root cause analysis activities in order understand and resolve product and process issues.
- Lead cross functional teams to improve current Cardiac Care products. Focus will be to address current product issues in the areas of quality, reliability and compliance to standards and regulations.
- Analyze and interpret Quality Monitoring, field returns bench test and other information to understand and correct design, manufacturing, and user-related problems.
- Document all phases of CAPA activity in compliance with applicable standards (incl. 21CFR part 820 and ISO 13485) and procedural requirements.
- Maintain timely information in the CAPA record. Must be knowledgeable in CAPA investigation techniques, including Failure Modes Effects Analysis (FMEA) and performing risk analysis relative to ISO 14971.
- Support activities as they are related to sustaining engineering and CAPA projects.
Company
Our client simplifies healthcare by focusing on the people in the care cycle - patients and care providers. Through combining human insights and clinical expertise, they aim to improve patient outcomes while lowering the burden on the healthcare system. Our client delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home.
Agreements
Up to 115k plus 10% bonus opportunity. Exceptional benefits. No relocation assistance will be provided, subsequently a local candidate is strongly preferred.
Candidate Profile
- Bachelor’s degree in Electrical Engineering with 8-10 years experience
- Experience in addressing Corrective Actions in a regulated industry
- Ability to understand, review, and document complex design issues
- Ability to effectively communicate technical findings and write technical reports on subject matter
- Demonstrated competence in performing effective troubleshooting. Excellent problem solving skills (root cause analysis)
- Proficient in analog/digital electrical design concepts
- Proficient with MS Office
- Ability to work on problems with limited direction
- Practical experience with FDA/IEC 60601-1 Safety standard for regulated medical devices
- Demonstrated knowledge of Quality Management System requirements: FDA Medical Device regulations (QSR) requirements, ISO13485 and applicable Medical Device Directives
- Demonstrated ability to work with electronic systems to evaluate circuit designs and sub-assemblies
- ASQ and Six Sigma training preferred
- Strong interpersonal skills
- Class III Medical device experience preferred
- Reliability Engineering experience a plus
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