Interim Senior Site Quality Manager
Columbia, MO, USA
Freelance
8 views
4d
Company Overview:
Our client is a Fortune 100 healthcare technology company that develops and manufactures medical devices, health care products, and advanced solutions used in hospitals, clinics, and labs around the world. Their portfolio includes surgical equipment, infection prevention products, wound care solutions, and other technologies that support clinical care and patient safety. With a focus on innovation at the intersection of health, material, and data science, the company is known for delivering solutions that help healthcare professionals improve outcomes and enhance operational efficiency. This interim opportunity provides the chance to contribute to a high-impact organization with a strong legacy of scientific and operational excellence.
Position Overview:
We are seeking an experienced Senior Site Quality Manager for an interim contract role at a high-performing medical manufacturing site. This position plays a critical leadership role in ensuring compliance with regulatory requirements and driving a culture of quality across the organization. The ideal candidate will be a strategic thinker with a hands-on approach, capable of leading quality initiatives, managing audits, and partnering cross-functionally to support continuous improvement. This is an excellent opportunity for a seasoned quality professional to make an immediate impact within a dynamic, fast-paced environment.
Responsibilities:
Management Representative with responsibility and authority to ensure Quality Management Systems (QMS) requirements are established, and effectively and efficiently maintained.
Conducts Operational planning to support the overall Quality strategy for the site and actively participates on the Plant Operating Committee (POC).
Plans, organizes and directs all quality activities and policies at the site. Establishing leadership and shared ownership for the Quality Culture within the site.
Assuring all products released to the market meet their specification and comply with relevant regulatory requirements (medical device and combination products).
Applying continuous improvement methodology to drive prevention of quality nonconformances and deviations, reduced variation in product and process, improved customer satisfaction, and operational excellence across the site.
Preparing for, managing, and following-up on quality and regulatory audits/inspections conducted by external agencies, notified bodies, customers, and internal functions.
Guiding the plant and business with appropriate risk-based decision making around deviations and change control.
Implementing quality and regulatory strategies aligned to global regulations and business strategic plans.
Developing the Team to deliver solutions for highly complex and multi-faceted problems, which require ingenuity, creativity, innovation, and strong analytical skills.
Networking effectively across all business stakeholders and sister plants within the business to share key learnings and capitalize on best practices.
Qualifications:
Bachelor's degree or higher AND seven (7) years of combined regulatory and/or quality experience within a heath care regulated industry at a private, public, government, or military environment
OR
High School Diploma/GED AND fourteen (14) years of combined regulatory and/or quality experience within a heath care regulated industry at a private, public, government, or military environment
Five (5) years leadership experience in health care industry
Proven ability to lead cross-functional teams and create excellent collaboration
Proven ability to lead audit/inspection activities
Experience leading continuous improvement projects
Change Management experience of programs with significant strategic importance
Demonstrated skills in customer experience management
Additional details:
This is a 6-month, 40 hours a week contract position working in the Columbia, MO site.
Talencio
Our mission is to be a catalyst for life-sustaining technologies.
Columbia, MO, USA
Freelance
8 views
4d
Company Overview:
Our client is a Fortune 100 healthcare technology company that develops and manufactures medical devices, health care products, and advanced solutions used in hospitals, clinics, and labs around the world. Their portfolio includes surgical equipment, infection prevention products, wound care solutions, and other technologies that support clinical care and patient safety. With a focus on innovation at the intersection of health, material, and data science, the company is known for delivering solutions that help healthcare professionals improve outcomes and enhance operational efficiency. This interim opportunity provides the chance to contribute to a high-impact organization with a strong legacy of scientific and operational excellence.
Position Overview:
We are seeking an experienced Senior Site Quality Manager for an interim contract role at a high-performing medical manufacturing site. This position plays a critical leadership role in ensuring compliance with regulatory requirements and driving a culture of quality across the organization. The ideal candidate will be a strategic thinker with a hands-on approach, capable of leading quality initiatives, managing audits, and partnering cross-functionally to support continuous improvement. This is an excellent opportunity for a seasoned quality professional to make an immediate impact within a dynamic, fast-paced environment.
Responsibilities:
Management Representative with responsibility and authority to ensure Quality Management Systems (QMS) requirements are established, and effectively and efficiently maintained.
Conducts Operational planning to support the overall Quality strategy for the site and actively participates on the Plant Operating Committee (POC).
Plans, organizes and directs all quality activities and policies at the site. Establishing leadership and shared ownership for the Quality Culture within the site.
Assuring all products released to the market meet their specification and comply with relevant regulatory requirements (medical device and combination products).
Applying continuous improvement methodology to drive prevention of quality nonconformances and deviations, reduced variation in product and process, improved customer satisfaction, and operational excellence across the site.
Preparing for, managing, and following-up on quality and regulatory audits/inspections conducted by external agencies, notified bodies, customers, and internal functions.
Guiding the plant and business with appropriate risk-based decision making around deviations and change control.
Implementing quality and regulatory strategies aligned to global regulations and business strategic plans.
Developing the Team to deliver solutions for highly complex and multi-faceted problems, which require ingenuity, creativity, innovation, and strong analytical skills.
Networking effectively across all business stakeholders and sister plants within the business to share key learnings and capitalize on best practices.
Qualifications:
Bachelor's degree or higher AND seven (7) years of combined regulatory and/or quality experience within a heath care regulated industry at a private, public, government, or military environment
OR
High School Diploma/GED AND fourteen (14) years of combined regulatory and/or quality experience within a heath care regulated industry at a private, public, government, or military environment
Five (5) years leadership experience in health care industry
Proven ability to lead cross-functional teams and create excellent collaboration
Proven ability to lead audit/inspection activities
Experience leading continuous improvement projects
Change Management experience of programs with significant strategic importance
Demonstrated skills in customer experience management
Additional details:
This is a 6-month, 40 hours a week contract position working in the Columbia, MO site.
Talencio
Our mission is to be a catalyst for life-sustaining technologies.
Job ID: 481464751
Originally Posted on: 6/16/2025
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