Job Description

JOB SUMMARY:

This role involves maintaining and improving quality engineering methodologies. This role requires more experience in supplier audits, quality improvement plans, and problem-solving. A deeper understanding of medical device manufacturing and quality systems is required. Can perform duties without supervision.

ESSENTIAL/PRIMARY DUTIES:

• Conducts activities concerned with the quality assurance of a given commodity set by working closely with suppliers, manufacturing, purchasing, and supplier quality.
• Analyzes processes and contributes to improvements.
• Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes.
• Assists in the review and approval of supplier corrective action plans and assists in the investigation of any supplier-related complaints.
• Identifies and communicates risks, participates in issue resolution, and mentors junior engineers.
• Assists in identifying/evaluating risks and contributes to risk mitigation.
• Participate in new product development teams and component qualification process as needed to carry out approvals for given components.
• Conducts and documents regular visits/audits to assigned suppliers to review manufacturing processes, quality systems/controls, pre-launch readiness, root cause identification, corrective actions, and process improvement opportunities.
• Has a commodity focus that is mixed between custom engineered components and distributed/off the shelf components and OEM products and actively works with Global Sourcing in new supplier selection and qualification.
• Applies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements utilizing six sigma techniques. May assist six sigma training at suppliers.

SECONDARY DUTIES:

• Assists in developing and maintaining supplier quality improvement programs and metrics.
• Participates in either back room or front room in support of MDSAP (or equiv.) audits.
• Assists in internal audits.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in engineering or related field and 2+ years of relevant experience, or equivalent experience. Six Sigma Black Belt certification will be required in the role.

COMPETENCY and/or SKILL:

• Effective communication with both internal and external stakeholders
• Working knowledge of FDA CFR 820 and ISO 13485
• Advanced analytical skills, ability to define and analyze complex problems

SUPERVISORY RESPONSIBILITIES:

• Provides leadership, coaching, and/or mentoring to co-op’s and engineer I’s.