HireDiversity

Raynham, MA, US

Complaint Product Quality Engineer II-7217121011

Description

Codman is currently recruiting for a Quality Product Complaint Engineer II position for Product Complaint Management in Raynham, Mass.

Codman & Shurtleff, Inc. provides products for the surgical treatment of neurological and central nervous system disorders through products such as hydrocephalic shunt valve systems, implantable drug pumps and micro-surgical instrumentation. A key focus area for this role will be with the Medstream pump line as it launches in the U.S.

The Quality Product Complaint Engineer II will perform activities such investigation of customer complaints for product quality issues and concerns. He/she will initiate product failure investigations and take the lead in failure investigation teams. The Quality Product Complaint Engineer II will conduct health hazard evaluations working with manufacturing, R&D, and Medical Affairs personnel as required.

In this role the Quality Product Complaint Engineer II position will develop and utilize statistical tools to analyze complaints for trends, root cause analysis, and initiation of corrective action. This role will be summarizing the results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management. This will include summarizing data to support activities such as post market surveillance, routine complaint reports, regulatory agency responses etc.

This Quality Product Complaint Engineer II role will also interface with key business partners including R&D, Operations, Medical and Marketing to ensure a thorough investigation is completed. Investigations can include user interviews and occasional customer visits to ensure rapid response to field safety issues. Depending upon the nature of the identified safety issue/product quality event, the Quality Product Complaint Engineer II will be the key interface with the Product Escalation group to ensure all events are escalated in a timely manner and per procedure. Providing daily support to the complaint team and help drive complaint investigations with various manufacturing sites in the U.S. and internationally ensuring complaint investigations are robust and well documented.

Qualifications


A minimum of Bachelors Degree is required. A Bachelors Degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or Electronic Engineering is highly preferred. A minimum of 3 years experience in the medical device or related field (ie: Pharmaceuticals, Biologics) is required. Class III device experience is preferred. Excellent problem solving, decision-making, and root cause analysis skills is required. Strong proficiency with the Microsoft Office Suite is required. Strong working knowledge of the QSR and ISO quality requirements is required. Knowledge of process and design excellence tools and Green or Black Belt training are a plus. Strong data analysis skills and presentation skills are required. Excellent communication and presentation skills are required. Experience with medical device utilizing software is required. The ideal candidate for this role will have the ability to collaborate with business partners at all levels across multiple functional groups in an environment that embraces teamwork and risk-based decision making.

This position may require up to 10% domestic travel and is based in Raynham, MA and does not offer relocation benefits.

Primary Location:North America-United States-Massachusetts-Raynham
Organization: Codman & Shurtleff Inc (6087)
Travel:Yes, 10% of the time
Job Function: Quality Assurance