Product Surveillance Sr Engineer II - Zimmer - Warsaw, IN (relocation available)

Looking for candidate with Bachelor's degree (engineering or ABET accredited) - fresh grad up to 6 years exp., process/development/quality engineering, regulatory compliance, FDA-regulated, root-cause analysis a MUST, product complaint, safety, trend, continuous improvement.

Independently responsible for the investigation and resolution of product complaints of all scopes for the U.S. Reconstructive and Trauma divisions (implants and instruments). Fosters positive relationships with supporting functional areas to resolve product and process issues and drive continuous improvement. Leads detailed investigations, product trend reviews, and department continuous improvement initiatives. Prepares and presents product safety and quality issues to the Remedial Action Screening Meeting. Provides product and process technical leadership/coaching to salaried and hourly staff. Must be committed to corporate goals of customer satisfaction and continuous improvement.
Investigates customer complaints, drives timely root cause analysis, assesses the scope of complaints, and leads HHE creation as necessary to assess patient/user risk.
Interfaces with Development, Manufacturing, Quality Assurance, and other functional areas to ensure thorough issue root cause, identify and formulate corrective actions, and initiate corrective action plans where applicable.
Leads product quality trend data reviews within the department and across Product Surveillance.

Position requires extensive knowledge of Zimmer products, Zimmer business practices, and Zimmer business management systems.
Individual should be proficient with use of complaint and quality related IT systems and tools.
Effective technical report writing skills.
Excellent oral and written skills required.
Effective leadership, interpersonal, negotiating, and conflict resolution skills
Effective leadership skills.
Able to work independently in most cases.
BS in an engineering discipline or bachelor's degree in another field with ASQ CQE certification plus a minimum of 6-8 years experience in a process engineering, development engineering, quality engineering or regulatory compliance role within the medical device, an FDA-regulated, or precision product environment, or an equivalent combination of education and experience

Contact me at kimberly.hughes@rightthinginc.com to apply!
Responses to candidates will be on a qualified and as needed basis.