Senior Quality Manager

At Orchid Orthopedic Solutions, we're more than just a contract manufacturer of orthopedic devices; we're on a mission to enable a longer, active life. With a dedicated focus on implants, instruments, and groundbreaking technologies, we serve a range of dynamic markets, including joint reconstruction, spine, trauma, sports medicine, extremities, and dental. Our manufacturing facility in Bridgeport, MI spans 85,000 square feet and specializes in cutting tools for orthopedic, dental, and trauma applications, producing burs, pins, screws, drills, reamers, and saw blades designed to meet the highest quality standards.

About the role

The Quality Manager assures compliance and progress towards the established goals of the organization and quality department by developing and enforcing quality standards and good business practices. They communicate and ensure customer expectations and regulation requirements are met. The Quality Manager reports to the Quality Director.

Responsibilities

• Work positively and enthusiastically to promote a Quality culture and engage the organization.
• Act as a coach to your team, developing organizational strength through empowerment, curiosity, and resilience.
• Lead within the business to develop and deliver Quality objectives while acting as a business partner to achieve wider goals.
• Use knowledge of regulated industry to drive compliance, fostering understanding across the organization and clarifying responsibilities.
• Engender a quality culture through regular employee briefings to champion Quality initiatives.
• Advocate Lean Manufacturing to plan and develop a compliant yet agile Quality System.
• Promote and coach "quality at the source," focusing on variation reduction and process capability to drive quality performance.
• Develop organizational competence in Problem Solving methodology and coach teams in this area.
• Ensure the organization develops a data analysis framework supporting efficient reporting, decision-making, and prioritization.

Requirements

• Bachelor’s degree (Preferred)
• Master’s degree (Preferred)
• 8+ years of experience in Quality (Required)
• 7+ years of experience in a leadership role (Required)
• 4+ years of experience in a leadership role in a manufacturing environment (Required)
• Experience in an FDA-regulated environment (Preferred)
• 10+ years of Quality Leadership Experience in a Regulated Environment (Preferred)
• Certified Manager of Quality/Organizational Excellence (CMQ/OE) - ASQ (Preferred)

Skills

• Accuracy and Attention to Detail - Working Experience
• Change Leadership - Extensive Experience
• Communication - Extensive Experience
• Customer Communication - Working Experience
• Computer Knowledge - Working Experience
• Data Analysis Tools - Extensive Experience
• Decision Making and Critical Thinking - Extensive Experience
• Inspection Knowledge - Working Experience
• Manufacturing Industry - Extensive Experience
• Organization - Working Experience
• Power BI - Basic Knowledge
• Standard Operating Procedures - Extensive Experience
• Leadership - Extensive Experience
• Problem Solving - Extensive Experience

Physical Demands

• Must be able to remain in a stationary position - Frequently
• Must be able to move about the inside of the building - Occasionally
• Must be able to communicate and exchange information with others - Constantly
• Must be able to distinguish and detect information such as writing and defects - Constantly

Benefits

• Performance bonuses
• Insurance coverage
• 401(k) plan with company match
• Paid time off
• Engaging employee events
• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Work in an organization that values integrity, teamwork, and results

Candidates offered employment may be required to submit to a pre-employment background check and drug-screening. Applicants must be authorized to work for ANY employer in the U.S. and must provide proof of eligibility to work in the United States through eVerify.