Quality Manager

Department: Quality
Reports to: Director of Operations - Converting

Position Summary

The Quality Manager is a hands-on leader responsible for the quality management system, food safety and regulatory compliance, customer quality support, and team development for Preco's Converting operations. This role owns the day-to-day execution and continuous improvement of the site's quality systems with emphasis on ISO 13485, SQF, audit readiness, CAPA effectiveness, and a strong quality culture. The Quality Manager is expected to mentor and develop the quality team, work cross-functionally with operations, engineering, and commercial teams, and drive practical, scalable systems that support both customer requirements and business growth.

Job Responsibilities

Provide Leadership & Team Development

1. Own and maintain site compliance to applicable quality and regulatory standards, with primary emphasis on ISO 13485, SQF, FDA/GMP expectations, and customer-specific requirements.
2. Serve as site quality leader for internal audits, third-party audits, customer audits, corrective action, management review, document control, calibration, training, risk management, and nonconforming material control.
3. Act as a working manager who coaches, mentors, and develops quality engineers, technicians, and inspectors while also directly supporting key quality system activities.
4. Drive CAPA discipline and structured problem solving; ensure root cause, containment, corrective action, verification of effectiveness, and lessons learned are completed with rigor and urgency.
5. Partner with operations leadership to standardize processes, improve accountability, and build a culture where quality, food safety, and customer requirements are embedded in daily execution.
6. Support customer qualification activities, quality reviews, complaint response, and escalation management as a professional and credible customer-facing representative.
7. Lead or support supplier quality development, incoming quality expectations, and risk-based controls where supplier performance affects product or food safety outcomes.
8. Develop and execute training programs that improve employee understanding of the QMS, FSMS, GMPs, traceability, and quality expectations.
9. Establish and report meaningful quality metrics, audit performance, CAPA status, customer issues, and system health indicators to site and executive leadership.
10. Ensure quality systems are practical and scalable for growth, including stronger visual controls, layered accountability, and clear ownership across functions.
11. Completes other tasks as assigned by the supervisor

Job Requirements

• Bachelor's degree in Engineering, Life Sciences, Food Science, Quality, Operations, or a related technical field.
• 8+ years of quality experience in a regulated manufacturing environment.
• 5+ years of direct leadership experience managing, mentoring, and developing a quality team.
• Direct experience leading or maintaining systems governed by ISO 13485 and/or SQF in a manufacturing setting.
• Strong working knowledge of audits, CAPA, nonconforming material, document control, training systems, calibration, risk management, and management review.
• Demonstrated ability to influence cross-functional teams and hold standards in a collaborative, hands-on environment.
• Strong written and verbal communication skills, including customer and auditor interaction.
• Comfort operating as a working manager in a growing business where both leadership and direct execution are required.

Preferred Qualifications

• Experience in both medical device / ISO 13485 and food safety / SQF environments.
• Experience in contract manufacturing or customer-driven manufacturing environments.
• ASQ certification (CQE, CQM/OE, or similar).
• Experience supporting FDA-regulated operations, validation activities, and supplier quality programs.
• Experience leading quality teams through business growth, organizational change, or multi-standard compliance environments.

Physical Demands

• Extended hours of sitting, viewing a computer screen, and keyboard/mouse operation.
• Direct communication with company personnel and external customers.

All Preco, LLC employees are empowered to stop production and notify their supervisor/manager if an unsafe act or product quality concern is occurring.  Also, each member of the Preco – Somerset team is responsible for identifying continuous improvement opportunities and participating in problem-solving teams as necessary