Quality Inspector - Medical Devices

Job Description

Job Description

Direct Applicants Only.

Sage Product Development, Inc. provides fast, efficient and creative product development and manufacturing services to medical device companies. We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between.

We combine a high level of experience with a low overhead company structure. We are all about solving client companies’ technical challenges and meeting their product development needs in a timely, efficient and highly personalized manner.

GENERAL SUMMARY:

• Play a key role in ensuring product integrity, compliance, and overall quality throughout the materials control and 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.

ESSENTIAL JOB FUNCTIONS:

• 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.
• Participate in maintenance and enhancements to Sage’s materials control system including procurement, incoming inspections, shipping and receiving, kitting, and inventory management.
• 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.

OTHER DUTIES AND RESPONSIBILITIES

• Any other duties as assigned.

REQUIRED COMPETENCIES

• Manual dexterity: Skilled hands and excellent hand-eye coordination are required to ensure proper completion of device assembly tasks.
• Ability to work efficiently and independently is required.
• The ability to communicate clearly both verbally and in writing is required.

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.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES:

• High School diploma, or equivalent.
• Minimum of 5 years working in a manufacturing/quality environment for medical devices.
• Proficiency with tools needed for inspection (calipers, micrometers, vision systems, etc.).
• Proficiency 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.

SUPERVISORY RESPONSIBILITY:

• None.

REPORTS TO:
Director of Manufacturing

WORKING CONDITIONS/PHYSICAL DEMANDS:

• 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.