Position Summary:The Team Lead organizes and leads quality inspection team through quality assurance operations, working with engineers in set-up and calibration tasks and carrying out rework and quality assurance procedures related to production or operations. Collects and evaluates data to assist in assessing and documenting results of quality assurance and control processes. Determines developing methods and procedures for quality assurance and control. Drives team towards performance enhancements to make operations more efficient and work towards department and company goals.
Essential Functions:- Ensures consistent application of quality procedures and processes necessary for successful and compliant inspection of product
- Sets daily, weekly, and monthly team/individual goals required to meet corporate goals, demand, and regulatory requirements
- Partners with Quality Engineering to qualify and validate inspection equipment and processes
- Keeps accurate records for all calibrations, reworks and deviations
- Performs other duties as assigned
- 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 accommodation may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Typically requires a minimum of 6+ years of related experience
- High school diploma or equivalent required
- AA in a technical field preferred
- Strong written and oral communication skills
- Good organization and documentation skills
- Advanced ability to work effectively and efficiently in a team environment and drive performance of daily objectives
- Intermediate proficiency in ASME Y14.5M and blueprint reading
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
Travel and/or Physical Demands:The physical demands listed here are representative of those that must be met by an 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 10 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.
