Associate Quality Systems Specialist

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Role Purpose Maintaing ClearCorrect's Quality Management System by ensuring company procedures comply with regulatory and ISO requirements. Being responsible for the administration of quality policies and procedures.

Your Role You will:

• Maintain the company Quality Management System processes and procedures required to manage product and regulatory requirements
• Stay current with industry regulations and standards including 21 CFR 820, 21 CFR 803, ISO 13485, MOD/ MOR and MOSAP
• Implement site training program for quality systems and creates documentation required
• Maintain company documents and records
• Maintain the Nonconformity (NC/Rework/Deviation) program
• Maintain the Equipment Calibration program
• Maintain the Environmental Controls program
• Assist in maintaining the Supplier Controls Process and the Approved Supplier List (ASL) in coordination with multidisciplinary team
• Assist in maintaining the company Internal Audit programAssists in maintaining the company Corrective Action (CAPA) programAssists in maintaining the company Risk Management program
• Assist in scheduling yearly Management Review and in compiling management review data
• Accurately record and report of information as required
• Report on audit findings and remediation, CAPA reports, NCR's, Quality metrics
• Coordinate and prepare site audit from health authority, notified body and key customers
• Follow safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area
• Follow employee policy within the company

Essential Your profile:

• 2+ years’ quality experience in medical device manufacturing field
• 2+ years’ experience in participating in internal and supplier audits
• 2+ years’ experience of producing formal procedures and work instruction
• 2+ years’ experience of basic utilization of quality tools, such as, RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts
• Support/ assist other departments for investigation, collecting metrics
• Basic computer skills (Microsoft Office)

Nice To Have

• Associate’s degree in quality, engineering, technical writing, English and/or manufacturing related discipline
• Familiarity with US and International medical device regulations
• 2+ years’ experience in leading internal and supplier audits
• 2+ years’ experience of producing technical documents, such as, draft management review, KPls at defined timeline, risk management for the quality system
• Lean/Six sigma Manufacturing knowledge
• Excellent written communication skills

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type: Full Time

Alternative Locations: Poland : Wroclaw

Travel Percentage: 0 - 10%

Requisition ID: 22169

22169