Quality Manager (Medical Instruments & Implants) Job Vacancy in C & S Machine Products Inc Niles, MI 49120 – Latest Jobs in Niles, MI 49120

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Company Name : C & S Machine Products Inc
Location : Niles, MI 49120
Position : Quality Manager (Medical Instruments & Implants)

Job Description : C & S Machine Products has an immediate need for a Quality Manager (Medical Instruments & Implants) for our Medical Device division located in Niles, Michigan. We are a contract manufacturing facility that produces custom precision products. This is a fast-paced, highly-regulated industry and we are looking for a strong, organized leader who can manage a fast-paced department with a new & expanding product line.Position requires at least 8 years of Quality Management experience along with at least 3 years’ experience in medical device (instruments & implants) manufacturing. This is a “working manager” role that will spend a lot of time on the production floor interfacing operators and technicians, working on CAR’s, and engaging with customers.Knowledge of Quality Standards for medical device products is a MUST. (Aerospace experience helpful) A background in high-mix / low-volume contract manufacturing is ideal.Responsibilities include:Full Management & execution of the quality management system (QMS) to ensure compliance with regulatory & customer requirements.Manages internal or external supplier audits and certifications. Performs root cause and correction action analysis and ensures preventative actions are implemented.Takes part in quality investigation, impact analysis and first article inspection processes, and oversees the technical library, ensuring that the Quality Management System, Process Documentation and Training Manuals are updated and distributed to appropriate team members timely.Coach, mentor, develop, direct, train, and evaluate the work of quality improvement personnel.Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.Ensure customer satisfaction with product quality.Receive and provide communications and related materials and reports regarding parts revisions, parts on hold, questions on dimensions, parts rejections, parts changes, qualifications, validations, internal audit data, and other quality-related information the customer requires.Receive, interpret, and implement corrective action procedures for product quality that the customer requires.The Successful Applicant:Bachelor’s Degree (Engineering related) preferred8+ years of experience in a manufacturing environment, specifically in metal working or medical device manufacturing preferredProject Management and Lean Manufacturing experienceExcellent communication and interpersonal skillsWorking knowledge of ISO 9001:2015 & ISO 13485:2015We Offer:Competitive base salary: $70,000-$100,000, depending on experience and skillsBonus Program: Company Gainsharing (effective immediately)Comprehensive benefits package including Medical, Dental and Vision, Medical/Prescription Drug Coverage, Life and AD&D Coverage, Long & Short-term disability coveragePaid Vacation & HolidaysRetirement Plan / 401(k) Match up to 4%Opportunity to work for a local world class company.C & S Machine offers long-term career growth potential in a team-oriented environment and is a drug free employer.Job Type: Full-timePay: $70,000.00 – $100,000.00 per yearBenefits:401(k)401(k) matchingDental insuranceEmployee assistance programEmployee discountHealth insuranceLife insurancePaid time offProfessional development assistanceReferral programRetirement planVision insuranceSchedule:Day shiftMonday to FridaySupplemental Pay:Bonus payApplication Question(s):Please describe your knowledge and experience with ISO 13485.Please list relevant experience related to this opening.What is your pay range expectation?If you were referred to this position, which employee referred you?Experience:ISO 9001: 1 year (Preferred)Medical Device Quality Management: 8 years (Preferred)Work Location: One location

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