Senior Quality Engineer

1720 embecta Medical II LLC; Parsippany-Troy Hills (NJ); Remote; USD 140,000 - 169,000; Full time

Job summary

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Senior Quality Engineer will ensure product complaint investigations, procedures, and activities comply with FDA QSR, ISO 13485, and ISO 14971 for vigilance.

This 100% telecommuting role reports to the Parsippany, NJ headquarters and can be performed remotely. It involves lab system upkeep, SOP revisions, and data analysis to support regulatory compliance and patient safety.

Qualifications

• Regulatory and international standards requirements including 21 CFR 820, ISO 13485, and ISO 14971.
• Experience in statistical methods for trend analysis and complaint data evaluation.
• Experience with CAPA, root cause analysis, and design change management for medical devices.

Responsibilities

• Ensure investigations and activities comply with FDA QSR, ISO, and Medical Device Directives.
• Review customer complaint investigations for validity and regulatory compliance.
• Revise SOPs and enforce equipment maintenance, hazmat and biohazard procedures.
• Support audits and provide audit preparation and tours.
• Program mechanical lab equipment and perform FTIR analysis and data evaluation.

Skills

Quality engineering

Root Cause Analysis

Design of Experiments

Statistical Analysis

CAPA

QA Audits

Education

Master’s degree in Engineering (any) or related field

Bachelor’s degree in Engineering (any) or related field

Tools

DHF Management

Quality Audit Management

Engineering Design Change Management

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 07054

Additional Locations

N/A

Work Shift

Not Specified

Must reference Job Title & Job Code: R21-00608359 EOE.

Equal Opportunity Employer

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.

At embecta, a career is more than a job, it is an opportunity to make a meaningful difference in the lives of about 30 million people around the world who depend on our products to manage a chronic condition every single day. As we expand our capabilities, reach, and impact, there’s never been a more exciting time to join us.

Follow embecta on LinkedIn