Supplier Quality Coordinator
Supplier Quality Coordinator
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Can be a fully Remote position however candidates in the Client Valley are preferred. Would be able to report onsite as needed.
Schedule: MF 85pm. OT not expected.
Interview Process: Video Interview with hiring panel. 12 rounds.
Travel: 5%. Minimal travel expected but possible.
Possibility of extension based on demand.
- This position works on compliance of suppliers of raw materials components and outsourced services for medical devices as well as suppliers of purchased finished goods that are registered medical devices.
- This position works closely with other functions within and outside of the organization (Manufacturing Quality Engineering Procurement Supplier Quality and suppliers).
Description of Work:
- Work with plants to identify the raw materials components and outsourced services that go into the manufacturing of medical devices.
- Work with Supplier Quality to have Quality Agreements in place for the suppliers identified.
- Review finished goods (FGs) and purchased finished goods (PFGs) labels for compliance to the appropriate standards.
- Work with suppliers of PFGs and the Contract Manufacturing Organization (CMO) to assure Medical Device Files are appropriate and meet the intent of relevant standards.
- Some travel may be required as part of the job responsibilities.
Education:
Required:
- Associates degree 3 years experience or
- HS Diploma 10 years equivalent experience
Experience:
Required:
- Minimum of 3 years of business experience in a regulated environment.
- Knowledge of applicable and similar industry requirements (e.g. ISO 9001 ISO 13485)
Preferred:
- Life Science product application knowledge and experience.
- Experience working in the Supplier Management space
- Green or Black Belt
Skills:
- Working knowledge of relevant software such as Microsoft Excel Word Power Point etc.
- Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
- Ability to influence individuals without authority and to motivate others within a project team
- Must be an effective communicator (written and verbal) highly organized motivated detail oriented with excellent analytical thinking and problemsolving skills.
- Ability to lead projects and coordinate the efforts of others to complete project goals; must also possess the ability to effectively manage conflict.
- Ability to lead change management and perform other duties as assigned.
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full Time
