Quality Assurance Technician

2 weeks ago

Dayton, Ohio, United States Globus Medical Full time

At Globus Medical, we operate with a sense of urgency to provide innovations that enhance the quality of life for patients with musculoskeletal conditions. Our team is motivated by the needs of these patients, as well as the surgeons and healthcare professionals who care for them. We foster a culture of exceptional responsiveness by collaborating with researchers and educators to convert clinical insights into practical solutions. Our offerings enhance surgical techniques and outcomes, enabling patients to return to their daily lives as swiftly as possible.

Position Overview:

We are seeking a Quality Assurance Technician to join our team on the second shift. In this role, you will be tasked with ensuring that we produce safe and compliant products for our patients. The Quality Assurance Technician will assist manufacturing by inspecting and testing products and supervising operations to ensure adherence to specifications and standards for medical devices.

Key Responsibilities:

  • Employ measurement tools such as Micrometers, Calipers, Pin Gages, Thread Gages, Comparators, Vision Systems, and Functional Gages to assess products.
  • Leverage organizational knowledge of inspection and calibration protocols to support the manufacturing floor and mentor others.
  • Conduct in-process and final product audits as well as process evaluations.
  • Report to Senior Quality Technician when discrepancies are identified.
  • Identify and manage nonconformities in line with company Standard Operating Procedures.
  • Gather data in compliance with Good Documentation Practices.
  • Prioritize daily tasks using a lean visual management system (Kan Ban, Heijunka, and FIFO) lanes.
  • Exhibit effective written and verbal communication skills.
  • Utilize Lean Manufacturing Visual Management Systems (Andon, Hour by Hour) to communicate issues effectively.
  • Collaborate as a team to resolve problems.
  • Perform duties in accordance with applicable FDA and state regulations, as well as standards including, but not limited to, CRF-820 and ISO 13485.
  • Additional responsibilities as assigned.
  • Comply with the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
  • Ensure compliance with relevant governmental laws, rules, and regulations, both domestically and internationally, by completing required training and maintaining knowledge of compliance as it pertains to your role.
  • Represent the company professionally and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with employees, customers, suppliers, and other third parties.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

  • High school diploma or GED.
  • Two to six years of experience in a manufacturing setting.
  • Proficient computer skills, particularly in Excel, PowerPoint, and Word.
  • Experience in performing inspection and testing methodologies.
  • Basic understanding of blueprint reading and GD&T ASME Y14.5.
  • Fundamental knowledge of GDP.
  • Basic understanding of machining, polishing, blasting, anodizing, cleaning, 3D printing, and assembly processes.
  • Fundamental understanding of measurement system principles, including Bias, Linearity, Stability, NIST, Test Accuracy Ratio, Attribute Agreement Analyses, Repeatability, and Reproducibility.
  • ASQ CQT certification is preferred.
  • Background in medical device quality systems, including 21-CFR820, ISO 13485, IEC, IEC 62304, and MDSAP.

Physical Requirements:

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this position.

  • Required to sit; climb or balance; and stoop, kneel, crouch, or crawl.
  • Must regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.
  • Required to possess specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Our Values:

Our Life Moves Us philosophy is founded on four core values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

  • Passionate About Innovation: We are dedicated to enhancing patient care by delivering advanced technology to our customers. Our commitment to improving the lives of patients drives us to continuously develop better solutions.
  • Customer Focused: We actively listen to our customers' needs and respond promptly.
  • Teamwork: We believe that together, anything is achievable. We value every team member and treat each other with respect. We hold each other accountable and provide support, making us collectively stronger.
  • Driven: We pursue our mission with energy and enthusiasm. We are agile, results-oriented, and decisive, overcoming challenges in our quest to deliver solutions that enhance the lives of our customers and patients.

Equal Employment Opportunity:

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin, or citizenship. We are committed to fostering a diverse workforce and value all employees' talents, supporting an inclusive and respectful environment.

Additional Responsibilities:

Please note that this job description is not intended to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this position. Duties, responsibilities, and activities may change at any time with or without notice.

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