QA Engineer at Entegee

Summary: Seeking a QA Engineer with experience in FDA regulated environments and strong knowledge of Quality System Regulation (QSR).

Requirements:

• Bachelor's Degree in an engineering related discipline.

• Minimum of 5 years of relevant Quality Management experience in an FDA regulated environment, ideally within medical device or in vitro diagnostics industry.

• Strong knowledge of FDA Quality System Regulation (QSR) with emphasis on Design Controls.

• Familiarity with current Good Manufacturing Practices (cGMP) and other relevant international and FDA regulations.

• Experience working with Quality Systems compliant with EN ISO 13485, ISO 14971, IVDD, and 21CFR Part 820.

Preferred Skills:

• ASQ or Six Sigma Certification or equivalent.

• Working knowledge of FDA IVD regulations and guidelines and/or experience with FDA and/or notified body audits.

Responsibilities:

• Compile, monitor, report quality metrics; prepare action plans for improvements as needed.

• Conduct internal audits; support timely completion of audit findings.

• Collaborate with teams to define action plans; support timely closure of Corrective and Preventative Actions (CAPA).

• Generate quality reports that track cycle times, yields/quality rates, evaluate trends through Pareto charts for various quality system and product performance metrics.

• Develop IQ, OQ and PQ protocols for measurement, test, quality system and instrument manufacturing equipment/software; execute protocols as necessary.

• Disposition, process, track non-conforming material reports (NCMRs).

Pay Details: $38.00 to $51.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.