Quality Manager

Essential Duties, Responsibilities, & Authority

* Quality Management System Ownership

o Lead, maintain, and improve the integrated QMS across ISO 9001, 13485, 14001, and 45001.

o Serve as Management Representative for audits and certifications.

o Ensure document control, CAPA, risk management, and internal audits are effective and timely.

o Works closely with customers to resolve complaints in a timely manner.

* Compliance as a Driver of Quality

o Position compliance as a tool for continuous improvement and customer trust.

o Translate regulatory and ISO requirements into practical, value-adding processes.

o Ensure swift & effective complaint/reject handling, investigations, and management reviews.

* Leadership & Team Development

o Manage and develop direct reports (compliance, quality, training/safety)

o Provide coaching and leadership to Compliance, Quality Supervisor, Quality Technicians, and Engineers.

o Ensure consistency in training, audits, and operator quality accountability.

* Cross-Functional Collaboration

o Partner with Engineering, especially NPD Quality Engineers, to establish clear and concise part quality standards, specifications, and inspection plans to meet customer requirements. This includes the approval and validation of new suppliers.

o Work closely with Manufacturing and CI to reduce scrap, improve visual inspection methods, reduce rework, and resolve systemic issues.

o Lead root cause analysis and corrective actions with cross-functional teams.

* Metrics, Reporting, and Improvement

o Define, track, and report KPIs for quality, compliance, and safety. This includes updating the weekly/monthly scorecard for team review.

o Responsible for the development and implementation of the 5S/GEMBA program, executed by the manufacturing team.

o Drive reduction in Cost of Quality (prevention, appraisal, internal & external failure costs).

o Work with Compliance Specialist & Training/Safety Coordinator to ensure safety training and compliance activities support ISO 45001 and environmental goals under ISO 14001.

* Follows environmental policies to protect and minimize our impact on the environment.

* Maintains a safe 5S working environment to minimize the possibility of injury. Acts in a safe manner always and ensures that those around them do not put themselves or others at risk. Reports any unsafe conditions to a manager.

* Performs other related duties and assignments as assigned or required.

Required Education, Credentials, & Certifications

* Bachelor's Degree in a technical discipline such as Engineering, Manufacturing or Quality Assurance.

* Six Sigma Black Belt preferred.

Job Specification

* 7+ years of quality/compliance leadership in manufacturing; medical device or plastics experience strongly preferred.

Knowledge, Skills & Abilities

* Experience in all aspects of Quality assurance including auditing and conducting ISO assessments, including risk-based thinking.

* Knowledge of FDA rules and regulations as they relate to medical device manufacturing (21 CFR Part 820 and Good Manufacturing Practices).

* Experience in EHS Management Systems including ISO 14001 and ISO 45001.

* Experience in Lean/5S methodologies

* Ability to interpret regulation, standards and guidance documents and implement requirements.

* Excellent written and verbal communication skills.

* Adaptable to balancing operational demands with long-term system improvements.

* Strategic decision-making skills based on risk.

* Strong analytical ability to use KPIs, cost of quality metrics, and trend analysis for decision-making.

* Ability to set company and departmental goals, outlines strategic plans for achieving goals and provides the resources to deliver results.

* Demonstrated experience developing people and processes, improving supplier quality, reducing costs, enhancing production process efficiency, and supporting cross functional collaboration.

* Must be a self-starter with the ability to prioritize effectively and execute successfully.