Manufacturing Quality Engineer

Job Description

Job Title: Manufacturing Quality Engineer

Location: Branchburg, NJ
Hire Type: Long-term contract

Target Pay Rate: $40-45/hour

Work Schedule: On-Site | Monday - Friday | 8:00am - 5:00pm
On-Call: Rotating weekly coverage for evenings and weekends

Benefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), & ESOP

Job Summary:

We are seeking a Quality Engineer to support Manufacturing Quality Assurance within a regulated manufacturing environment. This role will support deviation resolution, investigations, product impact assessments, CAPA, equipment validation, calibration programs, quality improvement initiatives, and compliance with applicable quality systems and regulations.

Must-Have Skills:

• Quality Systems & Regulatory: Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 / QMSR requirements.
• Risk Management & FMEA: Strong understanding of risk-management principles and experience with FMEA.
• Problem Solving & Root Cause Analysis: Ability to investigate manufacturing and quality issues, identify root causes, and drive effective solutions.
• Communication & Cross-Functional Influence: Ability to collaborate effectively across Quality, Engineering, Manufacturing, Operations, and other functional teams.
• Manufacturing Quality & Process Knowledge: Hands-on manufacturing quality experience with a strong understanding of production processes and quality requirements.

Job Duties:

• Support validation and certification of new process equipment and periodic reviews of certified systems.
• Implement and maintain the effectiveness of the Quality System.
• Ensure quality goals, procedures, and practices comply with company policies and applicable regulations.
• Lead and support investigations of plant events, including product impact assessments and CAPA activities.
• Support QA holds and other quality actions when appropriate.
• Participate in Validation Review Board activities as the Manufacturing Quality representative.
• Review and approve SOPs to ensure compliance and practical application.
• Review calibration requests and ensure appropriate product/process limits are established.
• Develop and implement statistical quality programs and acceptance sampling plans.
• Maintain strong working relationships with Quality, Manufacturing, Engineering, and other Plant departments.

Qualifications:

• Bachelor's Degree in Engineering, Biology, Chemistry, or related field, or equivalent relevant experience.
• 2+ years of experience in Manufacturing, Quality, Engineering, or a related field.
• Experience in a regulated manufacturing environment preferred.
• Strong verbal and written communication skills.
• Strong problem-solving and analytical abilities.
• Good interpersonal, collaboration, and negotiation skills.
• Knowledge of quality/compliance requirements and regulations affecting API, bulk drug, or finished goods manufacturing.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

Meet Your Recruiter

Mary Gallian


About Branchburg, NJ

Discover exciting job opportunities in scenic Branchburg, New Jersey, and surrounding areas! Embrace a career amidst a backdrop of picturesque landscapes, historic charm, and endless growth prospects. Whether exploring the historic Duke Farms, catching a show at the iconic Paper Mill Playhouse in Millburn, or savoring local delicacies like Taylor ham sandwiches, this region offers a blend of culture and opportunity like nowhere else. Join us in unlocking your potential and finding your dream job in Branchburg and beyond!