Perform external audits, as required, based on the published audit schedule and/or as needed if suppliers are struggling to achieve established quality metrics. Participate in supplier evaluations and help define the supplier audit schedule Other duties as required
BASIC QUALIFICATIONS | EDUCATION:
BS in Engineering, Manufacturing, Biology or related discipline or equivalent combination of education and experience. 2+ years’ experience in medical device industry, preferably in Quality or Supplier Engineering.
Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel
PREFERRED QUALIFICATIONS:
Familiarity with federal and other regulations, e.g. QSR’s, ISO 13485, CMDR, IVDD/IVDR. Working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures preferred.
High level of proficiency in Microsoft Office Suite of software applications is required.
High level of attention to detail and accuracy is required.
Strong organizational skills and ability to prioritize tasks is required.
Exceptional documentation and technical writing skills is required.
Excellent verbal and written English language skills is required.
Ability to establish and maintain strong, effective working relationships with internal employees and external customers is required.
Ability to react quickly and adapt to changes in priorities, circumstances and direction is required.
Must be able to reason independently and work with minimum supervision.
Ability to interpret data and make sound judgments based on those interpretations is required.
Must be able to adapt to quickly changing priorities and schedules.
Ability to maintain good working relationships with all co-workers and outside contracts is required.
21707940
TalentBurst is an award winning IT and Accounting & Finance staffing firm headquartered in Boston with branch offices in San Francisco, Miami, Milwaukee, Toronto, Bangalore, and Gurgaon. Our clients include the leading social media, technology, banks, utilities, pharmaceutical, and biotech companies.
We work with 75 of the Fortune 500 companies and work on 2,000 new job requisitions per month. Our recruiting team is one of the most successful in the industry. We have a strong reputation for treating our employees well and helping you find your next dream employer. Benefits
At TalentBurst, one of our founding principles has been to provide our employees with the best benefits available. To adhere to this principle, we have a broad benefits offering. Our recruiters are dedicated to connecting you with awesome career growth opportunities with leading companies.
5,000 to 9,999 employees