Quality Systems Engineer

OVERVIEW: The Quality Engineer is responsible for defining, implementing and maintaining an effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 13485 and other applicable country specific regulations. This position possesses the authority to approve quality system documentation (e.g. NCR’s, Procedures, W.I’s, CAR’s, etc., * Develop, implement, maintain and monitor quality metrics for the facility.

• Document quality systems and programs in quality trends, training, corrective and preventive actions, process control, customer complaints, etc. to ensure compliance with FDA, and regulatory requirements.
• Ensure corrective actions implemented are effective by verifying that repeat failures are eliminated.
• Lead regulatory inspections, ISO audits and customer audits.
• Support the Internal Audit Program. Participate in internal audits per schedule and review the results of all audits to ensure resolution of any noted deviations.
• Implement inspection / audit programs in manufacturing.
• Additional duties as requested or required.

• Speaks clearly and persuasively in positive or negative situations.
• Writes clearly and informatively
• Edits work for spelling and grammar
• Looks for ways to improve and promote quality
• Demonstrates accuracy and thoroughness
• Understands business implications of decisions
• Follows policies and procedures
• Follows instructions, responds to management direction
• Observes safety and security procedures
• Determines appropriate action beyond guidelines

LANGUAGE SKILLS:

• Ability to read, analyze and interpret general business periodicals, professional journals, safety rules, technical procedures or government regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from group of managers, clients, customers and the general public., * Bachelor’s Degree (B.A. / B.S.) from a four-year college or university in Engineering, Mathematics or Science; and 8 to 10 years of quality experience with medical devices in a FDA and or ISO regulated industry; or equivalent combination of education and experience., * Proficiency in Microsoft Word, Excel, PowerPoint and Outlook is required. Intermediate proficiency with statistical software packages, such as MiniTab is preferred., * The employee may occasionally stand, walk, stoop, kneel or crouch during shift. Employee will be required to regularly sit, use hand to finger, handle, feel and reach with hands and arms. Employee must be able to occasionally lift, push, pull and or move up to 25 lbs.