Qa Engineer - Med Device

QA Engineer - Med Device – Contract – Acton, MA - $39.00-$49.00/hr.

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

Our client is seeking a QA Engineer Med Device in Acton, MA.

Role Description

• Complaint Investigations (Time Spent: 45%):

• Review individual complaints and associated service data to determine risk level and complete investigation into the “as “determined” problem code and cause codes for each complaint.

• Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues.

• Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.

• Conduct corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.

• Support CAPA and maintenance activities for existing product lines.

• Recommend and/or support projects for improvements to the quality system as approved by management. Nonconforming Material Review Board (Time Spent: 45%)

• Support material review board

• Develop dispositions for nonconforming material using engineering / risk-based rationale.

• Coordinate the quarantine of nonconforming material.

• Communicate with suppliers about material that does not meet specification. Other (Time Spent: 10%)

• Provide quality support to various improvement projects.

• Perform quality duties as assigned by Quality Manager III.

Skills & Requirements

• A Bachelor of Science degree in Engineering

• 0-3 years of Medical Device experience

• Knowledge and working application of reading and understanding blueprints and technical drawings.

• Demonstrated strong analytical problem solving (Root Cause Investigations).

• Computer competency in Word, Excel, Power Point

• Ability to multi-task and methodically manage projects.

• Critical thinking

• Attention to detail

• Collaboration & Teamwork

• Dealing with Ambiguity

• Strong ability to balance multiple priorities

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

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Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.