Senior Quality Assurance Manager

Precision Concepts International (PCI) is seeking an experienced and results-driven Senior Quality Manager to lead all site quality functions and ensure compliance with customer, regulatory, and corporate quality requirements. This position serves as the designated Quality Management Representative for the Buena, NJ manufacturing facility and is responsible for driving a culture of quality, continuous improvement, and operational excellence throughout the organization. Quality Leadership & Operational Excellence Lead and manage all site quality functions, including Quality Control, Quality Engineering, Metrology, Validation, and Quality Systems. Drive continuous improvement initiatives that enhance quality, delivery, cost, and customer satisfaction performance. Partner with plant leadership and cross-functional teams to promote a culture where quality is integrated into all business processes. Develop, implement, and monitor quality objectives, metrics, and key performance indicators (KPIs). Build, mentor, and develop a high-performing quality team to support operational and strategic goals. Quality Management System (QMS) Maintain and continuously improve the site's Quality Management System (QMS) to ensure compliance with applicable standards and regulations. Collaborate with Corporate Quality and site leadership to develop, revise, and improve quality procedures and processes. Ensure effective implementation and maintenance of quality policies, procedures, and work instructions. Lead quality planning activities and support organizational quality initiatives. Regulatory Compliance & Audits Serve as the primary site representative for customer audits, regulatory inspections, and third-party certification audits. Maintain audit readiness and ensure ongoing compliance with applicable standards and regulations. Lead internal audit activities and corrective action programs. Collaborate with Corporate Quality to strengthen and improve audit and compliance programs. Manage responses to audit findings and ensure timely closure of corrective and preventive actions. Customer Quality Support Act as the primary quality contact for customers regarding quality concerns, audits, projects, and improvement initiatives. Support customer complaint investigations, root cause analysis, and corrective action implementation. Build and maintain strong customer relationships through effective communication and responsiveness. Quality Engineering, Validation & Technical Support Provide quality engineering support for manufacturing operations, process improvements, troubleshooting, and new product introductions. Oversee validation activities, including protocol development, execution, and documentation. Support process capability studies, Design of Experiments (DOE), Statistical Process Control (SPC), and data analysis initiatives. Ensure effective operation and maintenance of quality laboratories and metrology equipment. Training & Employee Development Develop and deliver quality-related training programs to employees at all levels. Promote employee engagement and awareness of quality systems, customer requirements, and regulatory standards. Establish departmental goals, performance objectives, and development plans for quality personnel. Support workforce planning, succession planning, and talent development within the Quality organization. Qualifications Bachelor’s degree in Engineering, Quality, Science, Business, or a related technical field required. Minimum of 7 years of experience in Quality Management, Quality Systems, or Plant Quality Operations within a manufacturing environment. Minimum of 3 years of leadership experience managing salaried and/or hourly employees. Experience in regulated industries, preferably medical device, pharmaceutical, healthcare packaging, or related manufacturing environments. Experience with plastics manufacturing and processing technologies preferred. Strong knowledge of Quality Management Systems and regulatory requirements, including: FDA 21, CFR Part 820, ISO 13485, ISO 9001 Experience with validation methodologies, Statistical Process Control (SPC), process capability analysis, and continuous improvement tools. Proficiency with ERP systems, Quality Management Systems (QMS), and Microsoft Office applications. The entry point salary for this role is $120,000 annually. We reserve the right to offer compensation above the stated salary reflective of years of technical experience, skillset, relevant industry experience, complexity, etc. This position is eligible for a comprehensive benefits package including medical, dental, 401(k), tuition reimbursement, and additional ancillary benefits available upon request. #J-18808-Ljbffr