Manager QC - Medical Device Manufacturing

Arthrex GmbH; Ave Maria (FL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Retirement Plan

Paid Time Off

Onsite Wellness Programs

Tuition Reimbursement

Bonus Program

Job summary

Arthrex, Inc. in Ave Maria, FL is seeking a Manager QC for Medical Device Manufacturing.

The role leads the Quality Control staff, drives continuous improvement, and ensures compliance with Quality System requirements across receiving, in-process, and finished device stages. The position requires a Bachelor's degree plus 5 years of related experience in medical device quality systems, with at least 3 years in supervision.

Qualifications

• Bachelor's degree required.
• 5 years of related experience, preferably in medical device manufacturing quality systems.
• 3+ years supervisory experience required.
• Experience with NCRs, CAPAs, Deviations and Quality System documents is preferred.

Responsibilities

• Lead, manage, and develop Quality Control staff to monitor and improve performance and product quality.
• Drive evaluation, monitoring, and continuous improvement of QC inspection methods.
• Coordinate approval of NCRs, CAPAs, Deviations and other Quality System inputs.
• Ensure nonconforming material is identified and communicated for timely resolution.
• Develop and maintain QC inspection plans and tests, using statistical methods where appropriate.
• Ensure First Article Inspections for all new or modified articles are completed.
• Ensure employees are properly trained and maintain departmental efficiency goals.
• Review and approve applicable Quality System documents.

Skills

Quality Control

Leadership

Coaching

CAPA

NCR

Quality Systems

Training

Education

Bachelor's degree

Tools

Excel

SAP

Job description

Manufacturing - Ave Maria, FL, US, 34142

Manager QC - Medical Device Manufacturing

Title: Manager QC - Medical Device Manufacturing

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a QC Manager, Medical Device Manufacturing for our manufacturing facility in Ave Maria, FL. The QC manager is responsible for managing, improving, and maintaining the manufacturing Quality Control activities to ensure products are manufactured to specifications that meet safety and efficacy expectations. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• 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.

Education and Experience:

• 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

Knowledge and Skill Requirements/Specialized Courses and/or Training:

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.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. To bend frequently and lift 50-70 lbs on a regular basis.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

Specific vision abilities required by this job include close vision.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.

• 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 Time Off
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.