Quality Associate

• This position has primary responsibility for driving overall quality performance throughout the supply chain.
• Specific responsibilities include:
• Develop and communicate expectations for quality performance, continuous improvement, quality systems, and process controls for both critical sustaining parts and new products.
• As required, participate as an active member in the new products development team.
• Perform and coordinate supplier: surveys, quality system, and process control assessments.
• Work with purchasing to measure and communicate supplier performance on key metrics and the corresponding continuous improvement plans.
• Collaborate with supplier representatives in establishing effective quality systems, process controls, and problem-solving methodologies.
• Conduct process and component validations as applicable.
• Monitor and drive corrective action and continuous improvement activities that directly impact performance for assigned suppliers.
• Conduct or lead event investigations and root cause analyses relative to purchased materials and components.
• Perform other duties as assigned.
• Run (F&T) tests in Minitab
• Handle incoming parts from suppliers
• Engage with suppliers and review documentation
• Use fixtures to measure parts; perform Gauge R&R (Repeatability & Reproducibility)
• Ability to read and understand technical drawings
• Knowledge or hands-on experience in auditing

III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED

• Knowledge & application of reading and understanding blueprints/technical drawings.
• Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
• Experience in manufacturing/quality assurance engineering in an FDA regulated environment.
• Knowledge and working application of standard operating procedures.
• Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
• Knowledge and working application of data entry and spreadsheet applications.
• Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
• Practical experience in metrology, test equipment, inspection and analysis techniques.
• Desired experience is in the medical device industry development and deployment of Quality System and process controls and continuous improvement methods (QSR, ISO13485).
• Desired CQE, CSSBB, CQA or initiative to complete certifications.
• Primary/Secondary party compliance auditing experience.
• Ability to multi-task and methodically manage projects.
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
• Effectively operate in and facilitate cross-functional teams with guidance.
• Must be able to provide solutions that reflect understanding business objectives and cost implications.
• Ability to: stand or walk for long periods, lift and carry at least 20 pounds, perform repetitive motions with hands/fingers.
• Demonstrated strong analytical problem solving (CAPA), teaming, and communications/interpersonal skills.
• Must be willing to travel as needed.

IV. EDUCATION/EXPERIENCE REQUIRED

• Bachelor’s Degree required.
• Lead Auditor training, ISO Lead Assessor training, with 1-2 years’ experience in auditing techniques, interpreting regulations and quality systems.
• Minimum of 3-5 years of experience in Quality, or related field in the medical products industry.
• 3–5 years (Medical Device and/or Regulatory Environment preferred)
• Bachelor’s degree preferred; Associate’s accepted if qualified