Quality Systems Engineer

TITLE: Quality 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.

This position is 100% on-site at 10888 Metro Ct., Maryland Heights, MO 63043.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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.

SUPERVISORY RESPONSIBILITIES:

This position has no supervisory responsibilities.

COMPETENCIES:

• 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.

EDUCATION, EXPERIENCE & TRAINING:

• 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.

CERTIFICATES, LICENSES OR REGISTRATIONS:

• None are required.

COMPUTER SKILLS:

• Proficiency in Microsoft Word, Excel, PowerPoint and Outlook is required. Intermediate proficiency with statistical software packages, such as MiniTab is preferred.

PHYSICAL DEMANDS:

• 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.

WORK ENVIRONMENT:

• This position works in an environment with moderate noise levels.

TRAVEL:

• This position may travel up to 25% of the time.

Note : Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Critical features of this job are described under various headings above. They may change at any time due to reasonable accommodation or other reasons. The above statements are strictly intended to describe the general nature and level of the work being performed. They are not to be construed as a complete list of all responsibilities, duties and skills required of employees in this position. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Savaria provides equal employment opportunities and consideration to all qualified employees and applicants, including disabled individuals and veterans.

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