[Hiring] Senior Quality Engineer @embecta

Role Description

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 assure 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 lieu of a Master’s degree, 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 is acceptable.
• 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.
• Engineering Design Change Management and DHF Management for Medical Devices.

Requirements

• 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.

Benefits

• EOE.
• 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.

Company 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.