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ISO Quality Manager/Engineer

Company: Prince Industries
Location: Carol Stream
Posted on: November 20, 2022

Job Description:

JOB SUMMARY Prince Industries is -seeking an ISO Compliance Manager who will be responsible for implementing, maintaining, and delivering quality and compliance within the company to achieve common quality and compliance policies. ESSENTIAL DUTIES AND RESPONSIBILITIES + Maintaining the company's ISO-9001 + Responsible for successful implementation and certification to ISO-13485 (Quality Manuals, procedures, and related documentation) + Report QMS metrics to top management and suggest improvements for performance + Evaluate and audit current QMS processes and documentation for compliance + Understanding of the MDD & MDR regulations + Liaison with external companies providing audit assistance + Liaison and management of Notified Body audits + Management and data provision to provide customers with compliance certification relating to various international requirements such as REACH, RoHS, Conflict Minerals, Certificates of Origin + Management of internal records relating to compliance and quality throughout the design/production/manufacturing process + Training of staff on quality and compliance issues including health & safety + Management of customer audits as well as auditing key suppliers and supplier visits EDUCATION AND EXPERIENCE + Bachelor of Science in Engineering (Mechanical, Manufacturing, or Industrial) + 5 + years working experience in a quality/compliance role + Familiarity with the various quality-related standards - including in medical devices + ISO 9000:1 Certification training required + ISO13485 / MDD/ MDR experience favorable + Understanding of medical devices is essential + Project management experience required QUALIFICATION REQUIREMENTS + Technical acumen + Project management orientated + Candidate possesses strong attention to detail + Strong verbal and written communication skills + Works with multiple stakeholders across various business levels BENEFITS + PPE Reimbursement + Tuition reimbursement for job related classes + PTO and 9 paid national holidays + Medical, Vision, and Dental Plans + 401(k) Retirement Plan through Fidelity + Life Insurance + Short-and Long-Term Disability Plans Powered by JazzHR

Keywords: Prince Industries, Carol Stream , ISO Quality Manager/Engineer, Executive , Carol Stream, Illinois

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