Quality Assurance Manager

PPC is the industry leading manufacturer of life-saving medical device components for over 42 years. We are looking for people who want to invest in their future, the future of PPC and our PPC community. Please refer to our website  for more information. This is a summary only. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We are an EEO Employer.

The Quality Assurance & Regulatory Affairs (QA/RA) Manager is primarily involved in the general oversight and maintenance of the quality management system (QMS) and quality engineering team. This would include, and is not limited to, review and approval of procedures, oversight of all auditing activity, dedication to ongoing improvements and performance enhancements across the business. Includes cross-functional team participation

• Work with the Head of Quality & Regulatory Affairs to maintain the department goals.
• Model continuous professional and communicative behavior.
• Participate productively and cohesively in internal and customer meetings, site visits and inspections as they occur.
• Work closely with peers to maintain cohesion amongst the departments and overall business.
• Independently manage competing priorities, allocates and assigns resources to meet target and timelines.
• Actively lead a multi-functional team.
• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Maintain programs and processes to ensure high-quality products and compliance with current GMPs and ISO standards.
• Assist in creating and maintaining a culture of quality and accountability among all employees to meet and exceed customer expectations.
• Provide leadership to set standards and expectations that promote teamwork, trust, ownership, excellence, creativity, innovation, and growth.
• Provide support and participate in IT projects to ensure deployments of systems meet relevant regulations, and that systems are maintained in a validated state (e.g., eQMS, PDM, ERPs systems, etc.).
• Monitor and report quality and compliance-related commitments.
• Supports general corporate operations by managing projects assigned in accordance with overall company and quality objectives.
• Develops and provides quality metrics and trend analysis reports for functions and leadership on a regular and as needed basis.
• Quality Management System (QMS):
• Thoughtfully apply ISO 13485 to the QMS and business practices.
• Oversee, maintain and improve the QMS by reviewing and developing processes, while including feedback from internal stakeholders and process owners.
• Maintain the function and development of the eQMS.
• Author, review and approve controlled documents.
• Own the change control process to support the continuous improvement of operational or quality processes via a formalized process and any subsequent customer notifications.
• Coordinate and communicate activities within the management/supervisory team.
• Coordinates and communicates process, product, and operational continuous improvement priorities within the department so those involved in Doc Control, CF’s, Training and Compliance are corporately aware of cross functional needs.
• Assist in the implementation and further development of quality and regulatory policies and procedures, in alignment with business objectives.
• Material Compliance, CAPAs, NCs, Feedback & Complaints:
• Manage customer and supplier requests for information, including but not limited to material compliance.
• Directly maintain and develop the CAPA, NC and complaint systems.
• Continuously teach and guide using techniques and methods for process improvements, efficiency, thorough investigations and root cause analysis.
• Tho…