Senior Quality Engineer

Embecta Corp.; New Jersey; Remote; USD 140,000 - 169,000; Full time

Job summary

Embecta Corp. is seeking a Senior Quality Engineer to ensure FDA QSR, ISO 13485, and ISO 14971 compliance across product development and lifecycle. You will perform investigations, support CAPA and change control, and ensure DHF integrity while collaborating with cross-functional teams.

The role emphasizes statistical analysis, regulatory knowledge, and audit support, with a fully remote work arrangement and reporting to the Parsippany, NJ headquarters.

Qualifications

• Master’s in Engineering or Bachelor’s with 5+ years in quality engineering.
• Experience with FDA QSRs, ISO 13485, ISO 14971 is required.
• Strong statistical analysis and CAPA skills are essential.

Responsibilities

• Lead product complaint investigations and V&V activities.
• Maintain and improve quality system procedures and SOPs.
• Support internal and external audits and vendor qualification.

Skills

Regulatory compliance

Statistical analysis

Root cause analysis

Design of Experiments

CAPA

QMS audits

Engineering change

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Tools

DHF Management

21 CFR 820

Job description

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 such as: Root Cause Analysis, Design of Experiments and Statistical Analysis; Quality Audit Management (Internal and External) - performing internal audits and representing the QMS during external notified body audits; Corrective and Preventive Action (CAPA) to investigate root causes; and Engineering Design Change Management and DHF Management for Medical Devices.Salary offered for the position is: $139,922.00 - $168,800.00/year.Primary Work Location:300 Kimball Dr, Parsippany, NJ 07054Additional Locations:N/AWork Shift:Not SpecifiedTo apply, submit a resume to https://nj.gov/labor/career-services/, OR submit a resume to https://www.embecta.com/en-us/careers, OR mail resume to Embecta Corp., Attn: HR, 300 Kimball Dr, Parsipanny, NJ 07054. Must reference Job Title & Job Code: R21-00608359 EOE.