Quality Manager (Medical Device Manufacturing)

Brief Description

Autocam Medical is a global contract manufacturer of orthopedic implants, spinal implants, precision instruments and orthopedic cutting tools. We offer a value-added approach to high-precision manufacturing, with specialties in CNC milling, turning and cutter grinding.

We are seeking a Quality Manager with a passion to make a meaningful contribution to the medical device industry. Reporting to the Director of Quality and the Site General Manager, the Quality Manager is responsible for developing and maintaining a quality system that ensures all products meet customer specifications and comply with ISO 13485 and regulatory requirements. This role aims to achieve superior quality, reliability, and value for customers while providing guidance and leadership to meet quality goals. The manager will promote the Autocam Medical Production System and uphold the company's high standards for quality and continuous improvement.

Responsibilities

• Provide leadership, direction, and mentorship to Quality Engineers, Quality Supervisors, Gage Calibration Technicians, and Quality Technicians/Inspectors to foster personnel development and achieve departmental goals.
• Ensure product quality through adherence to workmanship standards and quality system requirements. Recommend improvements to policies, procedures, and work instructions related to quality functions.
• Develop, implement, maintain, and improve a quality system that meets applicable national and international standards (ISO13485, 21CFR820, ISO9001, AS9100, etc.), regulatory requirements, and customer-specific requirements, ensuring audit readiness at all times.
• Act as a member of the site management team to establish site and quality department goals and objectives, ensuring product and service quality, and driving continuous improvement.
• Act as the management representative for the quality system, coordinating third-party quality system audits and liaising with regulatory agencies regarding compliance audits, complaint handling, and advisory notices.
• Serve as the voice of the customer, representing customer interests and promoting world-class quality within the organization. Facilitate customer communication regarding quality issues, product launches, and audits.
• Arrange and coordinate quality system management review meetings, including providing input data, leading the discussion. and documenting and following up on outputs and action items.
• Schedule and ensure the timely execution of quality system audits, including layered process audits and product audits, ensuring corrective actions are tracked and completed on time.
• Lead or support Area Improvement Teams in the pursuit of quality and continuous improvement initiatives.
• Ensure compliance with specific customer requirements related to product launch, PPAP, APQP, and quality systems.
• Provide guidance and support to gage laboratory personnel and gage calibration technicians.
• Identify and report quality problems or trends based on data analysis, providing insights to top management.
• Assist value stream areas in managing non-conforming products, ensuring proper identification, inventory control, and timely disposition.
• Support the Purchasing department in addressing supplier quality issues and assist in supplier evaluation, selection, and development according to company quality standards.
• Support training activities in quality-related disciplines, acting as a resource for coaching and mentoring.
• Meet with and travel to suppliers, customers, and other sites to discuss and resolve quality problems.
• Recommend and implement corrective actions to address quality issues, collaborating with the responsible departments and personnel as necessary.
• Assist in the development, implementation, and documentation of process changes, ensuring compliance with change control processes.
• Ensure proper maintenance of quality related files and records as required.
• Ensure the Quality Department is adequately staffed and manage personnel needs through planning and departmental budgets.
• Perform other duties as assigned.
  
  

Skills and Abilities:

• Ability to produce accurate and clear documentation consistently.
• Strong attention to detail and the capacity to handle multiple projects simultaneously while prioritizing tasks effectively.
• Excellent interpersonal skills to work collaboratively and tactfully with others, along with proven leadership capabilities.
• Correctable 20/20 vision and the ability to lift up to 30 pounds.
• Capacity to work at a desk for extended periods and remain on feet for up to three (3) hours.
• Ability to tolerate contact with cutting fluids and mineral spirits.
• Prior experience in quality assurance, with knowledge of the company's quality system and customer-specific contractual quality requirements.
• Understanding of basic quality system requirements and quality tools, including advanced blueprint reading and proficiency in interpreting and applying Geometric Dimensioning and Tolerancing (GD&T).
• Computer literacy and competence in using statistical tools, as well as detailed experience with gaging systems development and analysis.
  
  

Qualifications:

• Bachelor’s degree in Engineering, Quality Assurance, or similar field is required. Formal education in mathematics, statistics, and industrial practices is preferred.
• American Society for Quality (ASQ) Certified Quality Engineer (CQE) certification is preferred.
• Proven mechanical aptitude is required.
• Strong reading and math skills for interpreting technical documents used in manufacturing and quality assurance processes is required.
• Proven manual dexterity for tasks requiring precision is required.
• Excellent oral and written communication skills are required.
• Proven ability to work effectively with others, demonstrating strong people skills is required.
• Proven management and leadership skills to guide and develop team members effectively is required.