Job description

Job Summary:

The Senior Supplier Quality Engineer is responsible for delivering all aspects of the Supplier Quality Assurance function. Work in a team environment with suppliers to develop and implement best practices that emphasise defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all supplier requirements. Collect root cause analysis and provide corrective feedback to prevent line stops due to supply issues. Manage the supplier’s specific requirements and offer technical support. Responsible for ensuring that the products produced meet quality standards required to minimise quality costs and maximise customer satisfaction whilst ensuring that procedures and processes are adhered to. Maintain the robustness of product manufacturing following new product introductions to ensure continuity and improvement in supplier capability. Manage the customer specific requirements and offer technical support. Work on multiple phases or sub-tasks of projects or entire projects of high complexity, with results impacting on project completion.

Position Requirements:

o Generates and maintains incoming inspection procedures, via collaboration with suppliers. Trains inspectors to these procedures.

o Plans, coordinates, monitors, the incoming materials receiving and testing program.

o Manages the supplier audit program and performs supplier audits as needed based on supplier risk.

o Ensures adequate supplier chain controls are in place including quality and supply agreements.

o Participates in Management Review and represents supply chain metrics.

o Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components and sourced finished devices from a new supplier.

o Develops and/or sources inspection tools and equipment.

o Assists in generating components or sourced finished device specifications.

o Generate test protocols, monitor testing, issue qualification test reports, and approve components for use in products or source finished devices for distribution.

o Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.

o Analyses incoming material defects. Dispositions and drives corrective action as necessary (SCAR). Communicates issues to suppliers.

o Reviews new design specifications and provides input from component quality and manufacturability perspective.

• May supervise inspectors.

Education and Experience:

o Bachelor’s degree in science, manufacturing, engineering, business OR equivalent related industry experience required (pharmaceutical, biotechnology, and/or sterile production environments)

o Minimum 5 years in a leadership role within quality/compliance/regulatory

o Minimum 3 years of auditing experience

o Knowledge of Medical Device/Pharmaceutical/Biologic related regulations and standards (FDA, EUMDR, ISO13485, ICH)

o Experience with budgetary responsibility, product development, and supervision of groups/teams.

o Well-seasoned auditor with at least 40 audits completed designated as the Lead Auditor

Required Skills/Abilities:

o Strong ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others.

o Excellent organizational and time management skills with ability to set own priorities in a timely manner.

o High degree of flexibility and adaptability.

o Strong communication (verbal and written) and organizational skills.

o Basic computer skills required, such as knowledge of MS Word, Excel, and Outlook.

o High degree of integrity, transparency, and knowledge sharing

o Basic troubleshooting skills

o Excellent organizational, planning and time management skills.

o Ability to work effectively in both a team environment and an individual contributor role.

o Ability to perform in a high performing workforce.

o Works as a team player, participating in activities that involve cooperating with others.

o Ability to work and practical knowledge of clean room.

o Understands chemical and reagent supply chain complexities.

Physical Requirements:

o Prolonged periods of standing.

o Must be able to lift up to 25 pounds at times.

o Must be able to stand, bend, crawl, stretch, lay, and squat in order to maintain equipment.

o Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.

o Requires fingering, repetitive motion, talking and hearing.

o Significant work pace & pressure due to deadlines.

Job Type: Full-time

Pay: $67,682.09 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Saint Paul, MN 55107: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Quality audits: 5 years (Required)
• FDA regulations: 5 years (Preferred)

License/Certification:

• Certified Quality Auditor (Preferred)

Work Location: In person

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