**This position is onsite at our Mason, OH location. Candidates must be able to commute to Mason or have the ability to relocate in order to be considered.

POSITION SUMMARY:

This position will be responsible for the development and implementation of supplier-related quality system requirements to comply with international and domestic regulations in support of new product development, manufacturing, change management, and quality management system activities with a focus on continuous improvement.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Direct and support supplier-related activities, including:
  • QMS qualification and monitoring including supplier audits and assessments
  • Component (and sub-assembly) qualification elements such as defining requirements and assessing First Articles, Measurement Systems, equipment and process qualifications, Control Plans, etc.
  • Correction activities including managing NCRs and SCARs.
  • Suppliers change requests and improvement.
  • Knowledge of supplier's QMS operational linkages to ATRC requirements.
• Use strong working knowledge of domestic and international standards and controls relevant to the duties and expectations of this position.
• Work cross-functionally to overcome challenges and facilitate cooperation with suppliers to meet regulatory requirements.
• Operate with appreciable latitude for, and assume ownership of, actions and/or decisions on day-to-day activities.
• Determine appropriate response to novel or controversial problems that may impact the business significantly.
• Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics.
• Work closely with Quality Management and other departments in developing and executing company strategies.
• Assist with FDA and ISO audits. Perform internal and supplier audits as necessary
• Uses knowledge of best practices and technical proficiency in supplier quality engineering to mentor junior SQE's. Other duties as necessary and assigned

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others

• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor's degree (Engineering preferred) required or demonstrated equivalent combination of education, training and experience.
• 4+ years collective experience in a manufacturing discipline used to manufacture components (ie. Machining, Molding, MIM, Forming, etc)
• 2+ years ISO and regulated industry knowledge and audit experience.
• Knowledge of inspection methods for tangible components (ie. Mics, Calipers, Vision System, CMMs, etc)
• and
• Ability to travel to local supplier(s) location(s) when required.
• Ability to travel to out-of-town suppliers (approx <20%).
• Strong computer/data entry, report writing, and communication skills.
• Details-oriented with strong problem solving/trouble shooting experience
• Must be able to read technical specifications, blueprints, and drawings

PREFERRED QUALIFICATIONS:

• FDA and ISO 13485 knowledge and audit experience
• MDD, CMDR and JPAL knowledge
• ASQ Certified Quality Engineer
• ASQ Certified Quality Auditor
• Statistical use experience

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed

• Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
• Ability to pass pre-employment drug screen and background check

#LI-Onsite