26 days old

Quality Assurance Auditor

O&M Halyard, Inc.
Linwood, NC 27299
  • Job Code

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customersand their patientsare at the heart of what we do.

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.

Owens & Minor teammate benefits include:

  • Medical, dental, and vision insurance, available on first working day
  • 401(k), eligibility after 30 days of employment
  • Employee stock purchase plan
  • Tuition reimbursement
  • Development opportunities to grow your career with a global company

Quality Auditor Associates - Take the first step toward a career in the healthcare industry!

Shift: 12 Hour rotating Schedule (2 weeks on Days & 2 weeks on Nights)

Compensation: $16.63

Job Summary

To provide on-shift leadership and resourcing for Quality Compliance responsibilities, including ensuring material quality, statistical process control, product specifications, quality documentation, customer service and corresponding documentation are managed to meet team, mill, sector, corporate, customer, and business unit objectives and to comply with corporate and regulatory requirements. This position supports facility wide efforts for regulatory and corporate compliance, specifically providing final product release, management of quality nonconformances, and conducting periodic compliance audits for the base machines and converting lines. This position is also responsible for escalating compliance or quality concerns to Quality Leadership.

Core Responsibilities

  • Assist with the investigation and corrective actions of customer complaints.
  • Prepare for and support FDA, ISO, and Corporate Compliance Audits.

  • On-shift point of contact to understand, evaluate and provide guidance for quality nonconformances.

  • Review product history records and device history records for compliance to ISO and GMP requirements for base machine and the converting lines. Responsible for final product release on shift.

  • Ensure compliance to corporate and regulatory requirements (ISO 9001, ISO 13485, cGMP 820, ANVISA, Austrailia, CMDR, and MDD).

  • Conduct lab equipment calibrations/verification's and/or audit to ensure calibrations and verification are completed accurately.

  • Responsible for on-shift internal audits of existing processes, including but not limited to the following: (Audit Production Associate's and 3rd party lab and make sure they are up to date on lab certification, Audit lab records (test records, control charts, etc. for accuracy and completeness), Audit adherence to procedures and work instructions, and Audit product quality by visual inspection or physical testing).

  • Be a resource for the lab testers to answer questions about test methods, paperwork, data entry.

  • Maintain the lab equipment and be an expert on its function.

  • Identify and drive continuous improvement opportunities to improve quality and achieve objectives.

Qualifying Experience

  • High School Diploma or equivalent required
  • Associates or Bachelor's Degree is a plus
  • Attention to detail
  • Excellent oral and written communication skills
  • Proficient in Power Point, Excel, and Word

If you feel this opportunity could be the next step in your career, we encourage you to apply.

Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.

Note: Owens & Minor is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at our Company via email, the Internet, or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of our Company. No fee will be paid in the event the candidate is hired by our Company as a result of the referral or through other means.

Posted: 2020-07-17 Expires: 2020-08-15
Sponsored by:
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Quality Assurance Auditor

O&M Halyard, Inc.
Linwood, NC 27299

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