QUALIFICATIONS:

Required:

• Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university.
• A minimum of 6 years of relevant experience; OR master’s degree in related field plus 4 years’ experience.

Preferred:

• ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA).

Skills & Competencies:

• Proficiency in MSA principles, Geometric Dimensioning and Tolerancing (GD&T), methods of risk-management, Minitab statistical software, tolerance stack analysis, process and manufacturing controls, software quality concepts, CAPA, non-conformances, post-market surveillance, Microsoft Office tools.
• Strong analytical and creative problem-solving skills.
• Excellent verbal communication and technical writing skills.
• Possesses working knowledge in FDA, CE Regulatory, and New Product Design processes.
• Demonstrates technical coaching and leadership of peers.

Essential Functions:

• Ability to independently adapt behaviors and strategies to deal with emergent, non-routine and dynamic components of the job
• Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities
• Solid ability to understand complexity and navigate ambiguity to influence at the department level
• Plan and carry out multiple projects concurrently
• Ability to analyze problems and troubleshoot solutions
• Apply strong cognitive ability to collecting, processing, and disseminating information
• Understand current state and dynamics of the business
• Ability to foster teamwork, collaboration, negotiation, and influencing others
• Consistently open and approachable
• Engage colleagues and partners with the Enable Values in mind
• Ability to maintain a positive attitude, show empathy for others, and always do the right thing
• Ability to understand your own emotions and their effects on your performance
• Ability to express your emotions appropriately and have a positive impact on others in support of company goals and a healthy work environment
• Excellent time management skills
• Position requires being physically present on the premises during regular company hours or as approved by management

RESPONSIBILITIES:

• Manage supplier quality documents and conduct periodic reviews.
• Conduct periodic onsite and remote audits of critical suppliers.
• Manage supplier corrective action activities and completion of reports.
• Communicate with Supplier Quality Leaders on quality performance and areas for improvement.
• Support the data collection and analysis for Supplier Performance Scorecards.
• Approve new suppliers.
• Facilitate qualification of components including writing validation protocols and reports for component qualifications as needed.
• Ensure accurate and controlled supplier quality documents are generated.
• Drive improvements utilizing Lean methodologies using supplier scorecards and rankings.
• Coordinate inspection fixture procurement and integration of fixtures at the supplier.
• Troubleshoot material non-conformances with suppliers.
• Contribute to supplier continuous improvement activities.
• Develop and support strong collaborative relationships with external design/development, manufacturing partners and suppliers.