Education and/or Special Training
•B.S. in engineering (mechanical, electrical, or software preferred).

Job Description
Develops, implements, and maintains plans focused on ensuring quality and compliance of components and finished goods.

RESPONSIBILITIES
•Primary responsibility is to develop the overall quality approach for new products and line extensions within the new product development and specials process. This includes quality engineering oversight, quality systems implementation including test and inspection plans and product reliability during product development, verification, validation and design transfer while working with Regulatory Affairs Department to ensure compliance to FDA Quality System Regulations and ISO 13485.
•Primarily responsible for: Risk Analysis, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File.
•Contributor to: All PPQA Phase 1 and 2 deliverables.
•Driver of: All PPQA Phase 3 deliverables and Post Launch/Phase IV Deliverables.
•Primary participant in new supplier selection, validation, and contract development. Assists vendors in resolving manufacturing and quality issues as required.
•Responsible for initiating, reviewing, documenting and approving Engineering Change Orders (ECO’s)
•Partners with the operations team to develop and maintain a robust internal and external supply chain. Contribution examples include the performance of supplier audits, risk assessment/mitigation, and coaching.
•Assists and mentors the unit quality engineer in the trending and analysis of quality data (e.g. complaints, Tech Support trouble tickets, Pareto charts, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate.
•Authors and reviews procedures to ensure GMP and ISO 13485 compliance.
•Performs internal audits to verify compliance to documented procedures.
•Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
•Lead product quality related projects. Supports the business in addressing and solving quality problems
•May interact, by telephone or in person, with customers to resolve product issues as part of support escalation model.
•May train others on quality engineering related topics.
•Submits periodic reports on assigned topics to appropriate personnel.
•May coordinate the activities of 1 or more subordinates.
•May evaluate the performance of 1 or more employees based on pre-established performance parameters.
•Coaches and develops subordinates and production team members.
•Employee has the necessary authority to execute above mentioned job responsibilities, and will have authority to carry out specific responsibilities defined by quality system documents. Employee has authority to recommend and initiate preventative and correction action with regard to product non-conformances and quality system activities
Qualifications/Work Experience •Excellent analytical skills.
•Excellent interpersonal communication skills.
•Demonstrated ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), power tools and test/inspection equipment.
•Demonstrated mechanical/electrical or software problem solving skills.
•5+ years as Quality Engineer or equivalent.
•Experience in developing and working with small group problem solving teams.

Percent Travel Required 10