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Director Of Quality

Paragon 28, a Zimmer Biomet Company is looking for a Director of Quality to join the team in Englewood, Colorado. The Director of Quality for Paragon 28 will have overall accountability for Quality adherence throughout Paragon 28's US and international operations and will be responsible for all worldwide pre- and post-market activity in relation to quality affairs and assurance. This role works in conjunction with other management to establish long-range goals, strategies, plans, and policies related to the quality and compliance of Paragon 28's products. This position also has overall responsibility for the management of people within these teams.

Responsible for the overall development, implementation, maintenance, and overall success of Paragon 28's quality program and strategies.

Assist legal with device or process-related inquiries. Implementation, training, management, maintenance, and growth appropriate for the expansion of the Paragon 28 quality system within the Zimmer Biomet framework Provide strategic leadership and direction for the Quality Assurance team, including recruitment, training, coaching, performance management, and career development. Ensure the development, implementation, maintenance, and periodic update of a robust, ISO 13485-compliant Quality Management System that aligns with regulatory requirements and business objectives. Lead efforts in regulatory and quality compliance across all quality functions, including design control, manufacturing, supplier management, and product release. Collaborate with cross-functional teams (R&D, Operations, Regulatory, and Legal) to ensure product quality and compliance throughout the development lifecycle. Oversee creation and management of Design History Files and quality deliverables related to new product development and design control activities. Ensure supplier quality assurance through oversight of supplier evaluations, verifications, and inspection plans; support Purchasing and Product Development in the selection and onboarding of new suppliers. Drive continuous improvement initiatives based on quality data, trend analysis, audit findings, and customer feedback; manage root cause analysis and CAPA activities. Investigate and resolve quality issues, including non-conformities, deviations, and customer complaints, ensuring timely and effective resolution. Serve as quality liaison for mergers, acquisitions, and private label integrations, including due diligence and integration of acquired quality systems. Maintain up-to-date knowledge of global regulatory and industry standards, including ISO 13485, 21 CFR 820, ISO 10993 (biocompatibility), and others relevant to medical device development and manufacturing. Support internal and external audits and inspections, including FDA, notified bodies, and customer audits. Collaborate with executive management to provide regular reporting on key quality indicators and to contribute to overall business strategy and operational planning. Assist legal and regulatory teams with quality-related documentation, product inquiries, and regulatory submissions.

Bachelors degree in engineering or technical discipline and 10 years of related experience; may consider an equivalent combination of education and experience. Experience working within medical device quality management systems (QMS) Experience with ISO 13485 and 21CFR Part 820 Experience with GMP manufacturing or product development and quality controls Knowledge of EU MDR 2017 / 745. Minimum 7 years of management experience required. Demonstrated leadership capabilities to lead and manage teams and direct reports. Minimum 4 years as a management representative during onsite audits. Knowledge and experience with measuring equipment. Read and understand part drawings / GD&T. Excellent computer skills (MS Word, Excel, PowerBI). Knowledge of traditional orthopedic manufacturing (CNC, Additive Manufacturing, Anodization, etc.)

Work Environment : This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and copy machines.

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee frequently is required to move about the facility. The employee may be required to lift up to 15 lbs. by themselves.

Position Type / Expected Hours of Work This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined by the Manager.

Travel Expectations Up to 15% of overnight travel; potential for either domestic or international travel required

Compensation Data Salary range : $160,000 - $195,000 USD annually with eligibility for discretionary bonus