Senior Quality Engineer

Embecta Corp.; Parsippany-Troy Hills (NJ); Remote; USD 140,000 - 169,000; Full time

Job summary

Embecta Corp seeks a Senior Quality Engineer to ensure investigations, procedures, and activities comply with FDA QSR, ISO 13485, and Medical Device Directives for Vigilance. You will review customer complaint investigations for validity and ensure they are processed per corporate policies.

You will revise SOPs, enforce lab maintenance, conduct GLP-aligned analyses, perform FTIR testing, program lab equipment, and support internal and external audits.

Qualifications

• Regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971.
• Statistics for trend analysis and complaint data evaluation.
• Quality Audit Management (internal and external) and CAPA investigations.

Responsibilities

• Ensure product complaint investigations comply with FDA QSR and ISO standards.
• Review investigations for validity and ensure compliance with policies.
• Revise SOPs and enforce maintenance, hazmat, and biohazard/disposal protocols.
• Support internal and external audits and prepare for lab tours.

Skills

FDA/Quality System Regulations

ISO 13485

CAPA

Root Cause Analysis

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Job description

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.