QC Supervisor - Medical Device

Job Description:

The Inspections Supervisor is responsible for ensuring product is within quality standards and specifications. This includes, but is not limited to, maintaining quality and safety standards, visual inspections, measurements and functional testing of the product, recording data/test results to validate conformance, and assisting with quality related reports, reviews, and audits as needed. This role will oversee the Quality Inspectors and act to facilitate their work.

Essential Duties and Responsibilities

The following are the primary duties and responsibilities. Other related duties may be assigned as needed.

• Act as a resource for QC Inspectors - supervise, train, and participate in evaluations.
• Facilitate division of work and set schedules for QC Inspectors
• Program vision system equipment for use in inspections.
• Perform inspections of purchased parts, subassemblies, or finished products according to defined criteria and specifications.
• Use measuring equipment such as calipers, micrometers, gages, optical comparator, and computerized inspection devices as needed.
• Reject and return nonconforming materials and/or products that do not meet applicable specifications and requirements.
• Document inspection results by completing applicable inspection reports and logs.
• Ensure that department equipment is functioning by following operating instructions and calling for calibrations and repairs as required.
• Maintain inspection related documentation.
• Support the Quality Department with reviews, reports and audits as needed.
• Maintain a safe and healthy work environment by following standard operating procedures and complying with legal regulations.
• Participate in process and quality improvement activities.
• Take responsibility and ownership for all learning and training needs within the department.

Education, Training, and Experience

The following are the minimum qualifications an individual will need in order to successfully perform the duties and responsibilities of this position.

• High school diploma
• Minimum of 3 years of experience in QA, RA, or QC in a regulated industry with increasing responsibilities.
• Minimum 3 years experience leading and managing a team.
• Knowledge of FDA Regulations (21CFR820), ISO Standards (ISO 13485-2016), and other regulations as applicable.
• Knowledge of SOP development, cGMP, GDP, training programs, and audits/inspections.
• Affiliation with Quality professional organization such as ASQ and associated certifications (CQA, CQM/OE, CQE, etc.) preferred.
• Ability to articulate clearly; professional oral and written communication skills.
• Proficient in general computer programs such as Microsoft Office suite.
• Strong planning, organization, document review, and problem-solving skills.
• Good understanding and execution of investigations and root cause analyses.
• Ability to prioritize and multi-task with little supervision.
• Previous work experience should demonstrate good interpersonal skills, strong process improvement skills, self-motivation, flexibility, detail-oriented work style, professional attitude, and ability to effectively communicate with customers at all levels.
• Basic mathematical skills
• Legible handwriting

ABOUT DJO GLOBAL
DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. Our products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Our products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of our medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast, Chattanooga, CMF, Compex, DonJoy, ProCare, Exos, Dr. Comfort, DonJoy Performance and DJO Surgical.

For additional information on the Company, please visit www.DJOglobal.com.

DJO is a growing subsidiary of diversified technology leader Colfax Corporation

EOE AA M/F/VET/Disability

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.