Position Summary:The Supervisor is responsible for leading production personnel and overseeing daily manufacturing operations to ensure the consistent production of high-quality medical devices. This role supports site manufacturing strategy, drives operational efficiency, and ensures compliance with FDA regulations, quality system requirements, and company policies. The Supervisor provides direct leadership to line personnel and partners with cross-functional teams to achieve safety, quality, delivery, and productivity objectives.
Essential Functions:- Supervise and coordinate daily production activities to meet quality, safety, and output targets
- Provide direct leadership to production and line personnel, including work assignment, coaching, performance feedback, and accountability
- Ensure production processes are executed in accordance with approved procedures, work instructions, and quality standards
- Monitor and improve operational efficiency, standardization, and adherence to Analyze production data, defects, scrap, yield, and productivity metrics; implement corrective and preventive actions as needed
- Lead and participate in structured problem-solving activities related to quality issues, complaints, scrap, downtime, or throughput
- Ensure compliance with applicable FDA regulations, ISO 13485 requirements, internal Quality Management System (QMS) procedures, and company policies
- Support and participate in internal and external audits, audits readiness activities, and follow-up actions
- Ensure team compliance with safety, health, and environmental requirements
- Collaborate with engineering, quality, and other cross-functional teams to support process improvements and manufacturing initiatives
- Support site energy policy initiatives by promoting efficient production processes and participating in improvement activities that optimize energy usage
- Maintain clean, organized, and compliant production areas
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Bachelor's degree or an equivalent combination of education and relevant work experience required
- Minimum of three (3) to five (5+) years of experience in the medical device or regulated manufacturing industry required
- Minimum of three (3) years of experience in a supervisory or people-lead role required
- Experience analyzing, interpreting, and presenting detailed operational and quality metrics required
- Experience supporting or participating in internal and external quality system audits required
- Proficiency with manufacturing systems used to collect data and monitor or control processes required
- Demonstrated ability to effectively lead, influence, and motivate teams toward organizational goals required
- Strong working knowledge of FDA regulations, ISO standards, and quality system requirements required
- Excellent written and verbal communication skills required
- Strong organizational, time-management, and problem-solving skills required
- Ability to work effectively in a fast-paced, changing manufacturing environment required
- Ability to maintain regular and predictable attendance required
- Certifications relevant to medical device manufacturing or quality, such as CQE, Six Sigma Green or Black Belt, Lean certification, or structured problem-solving methodologies, preferred
- Knowledge of OSHA requirements and environmental, health, and safety standards preferred
Physical Demands:The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 15 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
