Job Description

Position: Quality Manager

Location: Warren, NJ (On-Site)

Length: Permanent

Job Description:

The Quality Manager is responsible for developing, implementing, and maintaining the organization’s Quality Management System (QMS) in compliance with ISO 9001 and ISO 13485 standards. This role ensures product quality, regulatory compliance, continuous improvement, and customer satisfaction.

Essential Duties and Responsibilities:

1. Quality Management System (QMS)

• Develop, implement, and maintain QMS aligned with ISO 9001 and ISO 13485 requirements
• Ensure documentation (quality manual, SOPs, work instructions) is controlled and up to date
• Ensure procedures and work instructions are applied through all the processes.
• Lead QMS reviews and updates based on regulatory changes

2. Regulatory & Compliance

• Ensure compliance with applicable regulations (e.g., FDA, EU MDR if applicable)
• Act as the primary contact during audits (internal, external, certification bodies)
• Maintain audit readiness at all times

3. Internal & External Audits

• Plan and conduct internal audits
• Coordinate external audits and certification processes
• Track and ensure closure of audit findings (CAPA)

4. CAPA (Corrective and Preventive Actions)

• Lead root cause investigations
• Implement and monitor CAPA effectiveness
• Ensure timely resolution of non-conformities

5. Risk Management

• Apply risk-based thinking
• Maintain risk management files and processes
• Ensure product and process risks are identified and mitigated

6. Supplier Quality Management

• Evaluate and qualify suppliers
• Monitor supplier performance
• Conduct supplier audits as needed

7. Training & Awareness

• Ensure employee training on quality standards and procedures
• Maintain training records and competency assessments

8. Continuous Improvement

• Drive continuous improvement initiatives (Lean, Six Sigma, etc.)
• Collect KPIs and quality metrics
• Lead management review meetings

9. Documentation & Record Control

• Ensure proper document control and retention
• Maintain traceability (especially critical for ISO 13485 environments)

Qualifications:

• Bachelor’s degree in Engineering, Quality Management, Life Sciences, or related field
• 5+ years in quality management
• Experience with ISO 9001, ISO 13485 is a plus

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

Job # 18440

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