Manager QC – Medical Device Manufacturing
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Ave Maria • Florida • United States
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About the role
- Leads, manages, and develops/coaches Quality Control staff to monitor and continually improve personnel performance and product quality inspection methods and effectiveness
- Proactively drives the evaluation, monitoring, and continuous improvement of quality control inspection methods and efficiency opportunities
- Reviews and coordinates intradepartmental approval of internal and externally generated NCRs, CAPAs, Deviations, and other Quality System inputs using established procedures and work instructions
- Ensures the nonconforming material identified from receiving, in-process, and finished device acceptance is identified, documented, and communicated to affected parties for timely and effective resolution
- Ensures quality control inspection plans, tests and methods are adequately developed (including test/inspection equipment), implemented, maintained and utilize statistical methodology, where appropriate, for receiving, in-process, and finished device acceptance
- Responsible for assuring First Article Inspections are completed for all new/modified articles
- Responsible for assuring employees are properly trained
- Responsible for maintaining and reporting departmental process efficiency goals, work assignments and throughput standards
- Responsible for the review and approval of applicable Quality System documents
- Strong communication, collaboration, and teamwork with other departments to ensure the effective execution of the quality system
- Ensure compliance within functional area and support the compliance objectives of the organization as a whole
Requirements
- Bachelor's degree required
- 5 years of related experience, preferably in a medical device manufacturing environment in quality systems, quality control, and/or quality engineering
- 3+ years supervisory experience required
- Strong leadership skills and ability to collaborate effectively with team members and stakeholders
- Familiarity with quality control concepts, test methods, equipment and applicable national standards relating to testing (i.e. ASTM standards, etc)
- Familiarity with applicable federal, military, FDA, ISO and EN specifications
- Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP
Benefits
- Medical, Dental and Vision Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Free Onsite Medical Clinics
- Free Onsite Lunch
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)
- Eligible for discretionary Long Term Incentive program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality controlquality systemsquality engineeringFirst Article Inspectionsstatistical methodologytest methodsinspection equipmentNCRsCAPAsDeviations
Soft Skills
leadershipcommunicationcollaborationteamworkcoachingperformance managementproblem-solvingtrainingorganizational skillsinterpersonal skills