Medical Device Quality Inspector

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

• Play a key role in ensuring product integrity, compliance, and overall quality throughout the inspection process.
• Support incoming inspection of materials, components, and subassemblies used in medical device manufacturing. Ensures suppliers’ products meet specifications and company quality standards to support safe, compliant production.
• Support manufacturing with in-process or final inspection or any other tasks as requested by the project leader.

• Perform standardized dimensional, mechanical and visual inspection of material, components and subassemblies for size, correct material, finish, appearance, and other pertinent requirements.
• Verify that materials, equipment, processes, and products comply with quality specifications.
• Dimensionally inspect products utilizing various measuring devices, such as calipers, micrometers and vision systems.
• Interpret engineering drawings and specifications and confer with quality, engineering, or leadership staff to determine conformance of product.
• Complete required inspection sheets and forms, maintaining necessary records or audits, dates inspector involved, acceptance or rejection and reasons, etc.
• Update inventory log and transfer materials, components and subassemblies to warehouse for newly accepted lots.
• Communicate and collaborate with operations personnel to ensure production needs are met.
• Work independently and manage daily priorities with minimal supervision.
• Ensure that work area and equipment are maintained in a clean, safe and orderly condition.
• Follow all Sage quality systems procedures as applicable.
• Prepare daily timesheets and submit completed timesheets on a weekly basis.

• Any other duties as assigned.

• Customer Focus
  • Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner.
• Management of Resources
  • Manage the incoming inspection area. Work in an organized and time effective manner. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.
• Communication Skills
  • Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations, and solutions clearly, logically, and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.

• High School diploma, or equivalent.
• Minimum of 5 years working in a manufacturing/quality environment for medical devices.
• Familiarity with tools needed for inspection (calipers, micrometers, vision systems, etc.).
• Experience reading and interpreting engineering drawings. Geometric Dimensioning and Tolerancing (GD&T) knowledge.
• Experience with AQL sampling techniques.
• Ability to interact with client companies in a professional manner.
• Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

• None.

Director of Quality

• Must be able to move throughout manufacturing, office and laboratory space, using a complete variety of office equipment, machinery and tools. Must be able to lift more than 25 pounds and stand for extended periods of time.
• Must be able to wear cleanroom gowning items (head cover, coat, gloves, shoe covers, facial covering if needed) and work in cleanroom environment for extended periods of time.
• Must be able to work with chemicals found in a manufacturing environment.
• The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.
• External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.