Quality Control Supervisor

The Quality Control Supervisor is responsible for floor operations i.e., Quality Control, but is also a caretaker of sitewide adherence and continual improvement of company programmatic Quality Assurance policies and procedures. This effort includes, but is not limited to, directly oversees a staff that includes hourly QC Inspectors of Level I and II, and Senior. This individual works with every department to ensure maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. 

Essential Functions:

• Direct and supervises the Quality inspection functions within the manufacturing facility. 

• Supervises the activities of employees in Quality and ensures compliance to procedures.

• Ensures purchased materials and manufactured products conform to specifications and quality standards.

• Confers with purchasing, customers, and vendors regarding specifications, errors, problems, complaints, compliance with government regulations, international standards and company requirements.

• Oversees quality control inspections on incoming materials and manufactured products.

• Manages and dispositions non-conforming material as part of MRB.

• Provides resources to addressing customer complaint investigations.

• Performs annual performance assessments of direct reports.

• Assists with equipment qualification on new inspection equipment.

• Assists Manufacturing and Engineering in implementation of new procedures, equipment, and methods as related to quality of product and cost reduction.

• Assists Manufacturing, and Engineering in identifying quality requirements and problems for the improvement and establishment of new and existing products, procedures, processes and methods.

• Provides resources for periodic vendor and internal audits to ensure system conformance, effectiveness and accuracy.

• Identifies, develops, and provides training for Quality Assurance staff, for Production Planning and Control, and Manufacturing as needed, as related to Quality Control norms.

• Provides support and expertise in the implementation and enforcement of ISO 13485, ISO 14971 and FDA Quality System Regulation.

• Communicates and support facility quality objectives.

• Helps to establish, follow, and improve company procedures.

• Provides written and oral reports to others to keep them informed of activities and results.

• Maintains a cooperative and motivational attitude with co-workers.

• 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:

• Strongly prefer education level of bachelors’ degree (science or engineering preferred) with a minimum experience of as follows,

• Minimum 2 years of experience leading others.

• Minimum 2 years inspection experience in a manufacturing environment in Quality Control or Quality Assurance roles with GMP and SOP’s to ISO standards. Preferring that inspection experience to be with a manufacturer of medical devices or similar environment of small lot CNC machining, 3D printing, various assembly and finishing processes.

• 4 years related experience in another manufacturing and FDA-regulated sector.

• Or education level of Masters with 2 years related experience. 

• Automated inspection system experience is a plus.

• Computer proficiency with MS Office and statistical analysis tools is required.  Solid knowledge of statistical process control theory, application, and calculation is required.

• Ability to use standard measuring equipment (i.e. Micrometers, Calipers, Height Gages, profilometer, ring, plug and thread, go no/go gages, dial indicator, surface plate, gage blocks and torque wrench) is required. Ability to read and interpret engineering drawings for medical devices, including Geometric Dimensioning and Tolerancing (GD&T) is required.

• Attention to detail

• Self-starter

• Advanced critical thinking and problems-solving skills

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 vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.