The Quality Manager - Injection Molding is responsible for leading site quality activities in a regulated manufacturing environment serving food, pharmaceutical, and medical device customers. This role ensures products are manufactured, inspected, released, and supported in compliance with customer requirements, company standards, and applicable regulatory expectations.
The successful candidate will provide hands-on quality leadership across injection molding operations, partnering with Operations, Engineering, Maintenance, Supply Chain, Regulatory, and Corporate Quality to drive product quality, process control, audit readiness, customer satisfaction, and continuous improvement.
Key Responsibilities- Lead the site Quality Management System and ensure effective execution of quality processes, procedures, and controls.
- Oversee quality activities for injection molding operations, including incoming inspection, in-process inspection, final inspection, product release, containment, nonconforming material, traceability, and lot control.
- Ensure compliance with applicable food, pharmaceutical, and medical device quality requirements, including GMP expectations, customer specifications, ISO requirements, and FDA-regulated quality system practices where applicable.
- Support process validation, change control, risk assessments, control plans, root cause investigations, CAPA, and continuous improvement initiatives.
- Lead customer quality activities including complaint investigations, containment, corrective actions, audit support, customer communications, and quality improvement plans.
- Partner with Operations and Engineering to improve process stability, reduce scrap/rework, improve first-pass yield, and strengthen process capability.
- Maintain audit readiness for customer audits, regulatory inspections, internal audits, and certification audits.
- Develop, coach, and lead quality team members while promoting accountability, compliance, and a strong culture of quality ownership.
Qualifications- Bachelor's degree in Quality, Engineering, Science, Manufacturing, or a related technical field preferred.
- Experience in injection molding manufacturing required; regulated industry experience strongly preferred.
- Experience supporting food, pharmaceutical, medical device, healthcare, or similarly regulated manufacturing environments preferred.
- Working knowledge of Quality Management Systems, GMP practices, ISO standards, FDA quality system expectations, CAPA, internal audits, change control, validation, new product launch, and customer complaint processes.
- Strong problem-solving skills, including root cause analysis, corrective action, risk-based thinking, and data-driven decision-making.
- Experience supporting new product launch activities, including validation planning, protocol execution, data review, and production readiness.
- Strong understanding of data analysis and process performance metrics, including Cpk, Ppk, confidence levels, statistical trends, and trend analysis to support quality decisions and continuous improvement.
- Demonstrated ability to lead cross-functional teams, influence operational
decisions, and communicate effectively with customers, auditors, and leadership.
- ASQ certification, Lean Six Sigma, or related quality certification preferred.
Ideal Candidate ProfileThe ideal candidate is a practical, hands-on quality leader who understands injection molding operations and can balance compliance, customer expectations, and manufacturing performance. This individual should be comfortable working in a fast-paced plant environment while maintaining strong audit readiness, disciplined quality systems, and a continuous improvement mindset.
