Job Description

POSITION DESCRIPTION (PRINCIPLE DUTIES AND RESPONSIBILITIES)

(12 Month + contract)

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

MAJOR DUTIES/RESPONSIBILITIES

• Support integration and remediation activities related to a new acquisition.
• Prepare and implement programs and processes to ensure compliance with the company's high quality standards.
• Support validation, MSA remediation, PFMEA (Risk Management), PPAP, QMS integration: manufacturing transfers, training, acceptance activities, part certification, NCs at suppliers and deep dive into P&PC.

REQUIREMENTS

• Bachelor’s degree required; degree in Engineering discipline preferred; Biomedical, Process, or Mechanical Engineering recommended.
• Minimum of 3 years’ experience in a quality role for a medical device company; this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment.
• Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable
• Excellent verbal, written and interpersonal communication skills
• Excellent problem solving and analytical skills
• Excellent technical writing skills
• Project management skills and ability to influence without authority
• Ability to read and interpret engineering drawings and other technical specifications preferred
• Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics)
• Knowledge of applicable regulatory requirements (ISO 13485, FDA Quality System Regulation, European Medical Device Regulations, etc.) desired
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc)
• Formal investigation and root cause skills preferred
• Formal process improvement skills preferred
• Process-based auditing skills preferred

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, and status as a protected veteran.

Company Description

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management. iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference! Contact us today to learn more: *** Grand Rapids, Michigan: 616.254.8586 *** Tampa, Florida: 813.463.8850 *** www.impactbusinessgroup.com *** Chat with us live: https://lc.chat/now/8608604/