embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care.
Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.
Senior Quality Engineer
Job Description Summary:
- Ensure product complaint investigations, procedures, and other activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.
- Maintain good laboratory practices (GLP) consistent with product development objectives and regulatory requirements.
- Review Customer complaint investigations for validity and assures they are processed and investigated in compliance with Corporate and Unit policies and procedures.
- Revise SOPs and enforce compliance with equipment maintenance protocols, hazmat management, as well as biohazard and disposal management on behalf of the laboratory team.
- Perform FTIR analysis to identify various materials, including completing foreign matter complaint investigations.
- Program mechanical lab equipment such as Chatillon.
- Perform qualitative and quantitative analysis and critically analyze data generated.
- Provide audit support (preparation, lab tour and related activities).
- 100% telecommuting role.
- Reports to company headquarters in Parsippany, NJ.
- Can work remotely or telecommute.
Qualifications:
- Master’s degree in Engineering (any) or related field of study and three (3) years of work experience in the job offered or related occupation in which the required experience was gained.
- In lieu of a Master’s degree in Engineering (any) or related field of study and three (3) years of work experience in the job offered or related occupation in which the required experience was gained, employer will also accept a Bachelor’s degree in Engineering (any) or related field of study and five (5) years of work experience in the job offered or related occupation in which the required experience was gained.
- Must also have demonstrated experience in the following:
- Regulatory and international standards requirements including 21 CFR 820, ISO 13485, and ISO 14971 to support quality engineering activities;
- Statistics for trend analysis and complaint data evaluation;
- Product failure modes;
- Quality Engineering tools