Senior Quality Engineer

Regulatory Toolkit; New Jersey; Remote; USD 140,000 - 169,000; Full time

Benefits offered by this job

Telecommuting

Remote work opportunity

Job summary

embecta, a global medical device company, seeks a Senior Quality Engineer in Parsippany, NJ to ensure investigations, SOP updates, and regulatory compliance across the quality system. The role emphasizes GLP alignment, audit support, and LAB equipment management.

The position requires advanced engineering education with substantial experience in regulatory standards, quality engineering tools, and CAPA processes within medical device contexts.

Qualifications

• Master’s degree in Engineering or BA/BS with 5 years’ experience, per listing.
• Experience with 21 CFR 820, ISO 13485, ISO 14971 and QMS audits required.
• Proven skill in RCA, CAPA, DoE and data analysis for quality investigations.

Responsibilities

• Lead product complaint investigations and ensure regulatory compliance.
• Revise SOPs and ensure GMP/GLP adherence for the laboratory team.
• Support internal and external audits and CAPA activities.
• Program lab equipment (e.g., Chatillon) and perform FTIR analyses.

Skills

Regulatory knowledge

Statistical analysis

Root cause analysis

CAPA

Design of Experiments

DHF management

Quality audits

Engineering change management

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering with 5 years experience

Tools

FTIR analysis

Chatillon equipment

Job description

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, anda commitmentto improving lives, we are expanding our portfolio of solutions to serve even morepatients, 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 07054

Additional Locations:

N/A

Work Shift:

Not Specified

embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.