Quality Assurance Operations Specialist
Memphis, TN 
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Posted 1 month ago
Job Description

Are you ready to work for a more active world?

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Quality Assurance Operations Specialist provides quality systems support to Quality Operations, QC/QA, Manufacturing and Engineering, to ensure that products are manufactured with a high level of quality, while maintaining compliance with local procedures and regulations governing medical device manufacturing. The person in this role shall be able to work independently and lead different quality assurance processes employing common sense and risk-based thinking in alignment with applicable regulations

What you'll be doing

  • Lead non-conformance investigations (product, manufacturing and procedural) utilizing proven root cause analysis techniques (fishbone diagrams, 5-Whys, process mapping, etc). Provide guidance and investigation assistance to solve significant or chronic process, product or software problems. Discuss customer problems with Marketing and Sales as needed.

  • Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams and upper management. Expected to identify adverse trends and propose/implement appropriate actions.

  • Understands the escalation cycle from non-conformance up through investigation, CAPA and other. Contributes to other quality systems, such as post-market surveillance and complaint handling when required.

  • Establishes and maintains quality systems elements as assigned by management, including ownership/support of such systems. Independently maintains these systems in a state of compliance with all applicable standards and regulations such as ISO 13485 and 21CFR820.

  • Supports/own Quality Systems elements as Internal Audit systems, CAPA, Non-conforming material disposition and investigations, Supplier monitoring.

  • Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.

  • Other duties as assigned

What you'll bring to the table
  • Bachelor's or Technical degree in Science or Engineering discipline or equivalent technical field, with emphasis on Quality preferred.

  • Minimum of 0-2 years of experience preferably working within the medical device industry with the ability to understand/interpret, regulations and guidelines governing medical devices including knowledge of ISO 13485 and 21 CFR 820.

  • Data analysis and critical thinking skills; Ability to adapt and learn quickly

  • Excellent written, verbal communication, and responsiveness

  • Ability to work well within a team and relate to all levels within the company

  • Understanding and experience in applying quality engineering concepts such as process capability analysis, risk assessment, PFMEA and DFMEA is desirable.

  • Experienced in the use of quality tools such as Failure Modes Effects Analysis (FMEA), Fish Bone Diagram, Risk Analysis, or other appropriate methods to define and manage risk or identify root cause of failure. Understanding and experience in applying quality assurance and control tools (statistical analysis, DOE, gauge R&R and SPC) is desirable.

  • Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations. Experience in supplier quality is a plus.

Bioventus requires proof that new hires be fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from being vaccinated where allowable under the law. Documentation is required to be uploaded within the first week of employment.

Are you the top talent we are looking for?

Apply now! Hit the "Apply" button to send us your resume and cover letter.

Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms ofdiversity andtake pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation.All individuals, regardless of personal characteristics, are encouraged to apply.


We are an Equal Opportunity Employer Veterans/Disabled

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
0 to 2 years
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