POSITION PURPOSE:

This role is responsible to provide QC inspector team leadership, manage the test/characterization lab. to deliver best-in-class product quality, on-time delivery and overall customer satisfaction. Participate as a key member for the QMS compliance to ISO13485 and changes required for greater technological understanding of products.

ESSENTIAL FUNCTIONS - The following list of essential job functions is not exhaustive and may be supplemented as necessary based on business needs.

• the QC Inspectors: manage the QC queue, prioritize lots for inspection, coordinate overtime balanced with queue and company guidance, perform employee annual reviews and individual management, cross training
• the test and inspection lab for advanced product testing supporting product and process development projects and reporting results
• inspections of products at incoming, in process and final as needed
• of measurement devices: verniers, digital micrometers, non-contact measurement devices, vision systems, optical comparators, surface profilometers, tensile testing, adhesion testing(s), viscosity testing, coefficient of friction testing and others as the business invests in new/novel test methodologies
• a technical asset in the specifying of new metrology, installing, debugging, and documenting in the use of the devices/test methods. Execute Gage R&R/test method validation with Quality Engineering
• quality related processes such as nonconformances, change control, calibration, customer complaints, CAPA (root cause analysis) and equipment qualification and process validation
• the Calibration Program
• investigations for NCMRs, CAPAs and Customer Complaints as needed, Root Cause Analysis
• Monthly Quality Objectives and support new objectives and metrics
• of the company quality management software data entry, routing and reporting and company ERP system (Data Analysis, Test Plan Creation, etc.)
• other related duties as assigned by management

SPECIFIC JOB KNOWLEDGE, SKILL AND ABILITY

The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation.

• knowledge of medical device QMS requirements including but not limited to FDA regulations and ISO 13485
• in use of Minitab preferred
• Reading and GD&T training preferred
• proficiency in supervising and motivating subordinates.

Ability to read, listen and communicate effectively in English, both verbally and in writing

Organized, detail oriented, flexible and willingness to work within changing priorities

Ability to navigate a computer ERP system, in certain modules, perform data entry and data retrieval

1. Willingness to continually work beyond scope of essential duties in order to assist whenever and wherever needed to ensure needs are met

Ability to lift and maneuver up to 20 pounds regularly. (larger weights may require assistance)

QUALIFICATION STANDARDS

Experience:

Minimum 10 years’ experience in medical device or contract manufacturing environment and minimum 5 years’ experience with direct reports in a Quality role

Education:

Bachelor’s Degree in a related field or minimum 10 years industry experience as a Quality Supervisor or Manager