Quality Control Specialist

Job Description

Job Description

Job Title: Quality Control Specialist

Shift: 8am-4:30pm, Mon-Fri

 

Qualifications:
• Experience in Quality Management Systems (ISO 9001, ISO 13485 or other regulated industry).
• Proficient use of hand inspection equipment (ie; calipers, micrometers, plug/thread gages)
• Proficient using/programming Keyence Vision System
• Proficient using MS Office products (word, excel, outlook, etc.)
• Proficient using e-QMS and ERP
• High Level of attention to detail and organization.
• Hard working, quick learner
• Excellent verbal, written and interpersonal communication skills.
• Able to multi-task and work independently. Ability to participate in cross-functional teams.
• Knowledge of Quality Concepts (e.g. QMS, Line Clearance, CAPA, Audits, GDP)
• Medical device or other regulated industry quality work experience (year+)
• Experience reading Engineering drawings/schematics

Responsibilities:
1. Completes QC inspection of LKC Medical devices per procedures and SOPs.
2. Completes incoming and final inspections of components per procedures, approved fabrication drawings, and material inspection plans.
3. Completes inspection and nonconformance forms accordingly.
4. Collaborates with Purchasing, Operations, and Quality to ensure nonconforming material is labeled and isolated to prevent use and approved material is part of inventory for job builds.
5. Reviews DHRs for completion and accuracy.
6. As required, manages the document control system.
7. As required, coordinates and manages training records.
8. As needed, assists with filing of records and supports external and internal audits.
9. As needed, maintains technical documentation and DMR files as an output of the Change Control process.
10. Follows relevant Quality Manual and SOPs and assists in ensuring regulatory requirements, industry standards, and company policies are implemented and met.
11. As needed, assists Purchasing/Operations and Quality in managing Supplier Corrective Action Requests and CAPAs.
12. As needed, assists with executing, filing, maintaining calibration equipment/logs/files.
13. Work closely with operations and the business functions to ensure quality performance of product and processes.
14. Participates in the creation and/or review of new or modified procedures
15. Other duties as assigned.

Education / Experience
• High School / GED required, bachelor’s degree preferred.
• Minimum of 3 years’ experience in a quality role for a medical device company; this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment.
• Professional certification in a quality subject matter (e.g. MS, CQE, CRE, Six Sigma) highly desirable.