Highlights
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. Problem Solving & Root Cause Analysis: Ability to investigate manufacturing and quality issues, identify root causes, and drive effective solutions.
Numbers & Facts
| Location | Branchburg, NJ |
| Industry | Staffing/Employment Agencies |
| Salary | $40–$45 Per Hour |
| Company Size | 500 to 999 employees |
| Year Founded | 1969 |
| Website | http://www.sterling-engineering.com |
Description
Job Title: Manufacturing Quality Engineer
Location: Branchburg, NJ
Hire Type: Long-term contract
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
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.
About Company
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.