The Senior Supplier Quality Engineer will develop, establish, and maintain supplier quality management practices that meet Agiliti, customer, and regulatory requirements.
PRIMARY DUTIES AND RESPONSIBILITIES
- Participate in all applicable Quality Management System (QMS) activities including document change management, records management, training/competency, non-conforming material reports (NCMRs), Complaint/Incident investigations and Corrective and Preventive Actions (CAPAs).
- Participates with quality members in the product development processes and documentation including, but not limited to supplier new product qualification and supplier development process.
- Execute tasks associated with continuous improvement activities.
- Provides data for predefined metrics for supplier monitoring.
- Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Ensures compliance with internal and external regulatory agencies.
- Facilitates accurate and timely completion of customer and quality records.
- Ensures that supplier corrective measures meet acceptable standards.
- Applies statistical methodologies for assessment and to resolve potential product and quality system issues.
- Leads small projects within team or across one to two departments.
- Work independently; minimal daily direction required to successfully develop deliverables.
- Leads qualification of supplier selection and approval process.
- Guides, supervises, and/or coaches others on the quality team. May supervise a team.
- Creates and maintains project schedules and delivery milestones for completion.
- Up to 50% travel required, with opportunity to plan travel schedule.
REQUIRED EXPERIENCE
- Bachelor’s degree in Engineering or life sciences required.
- Minimum 5 – 8 years Quality Engineering experience OR advanced degree with 3 – 5 years of applicable experience.
- Experience with ISO 13485, 21 CFR Part 820, and Medical Device Good Documentation Practices.
- Experience guiding and coaching others.
- 3+ years of experience leading supplier quality management and new product development projects, experience improving and maintaining an effective Quality Management System.
REQUIRED SKILLS & ABILITIES
- Proficient computer skills in MS Office Suite.
- Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485.
- Strong analytical skills including application of statistical techniques.
- Strict attention to detail.
- Strong technical writing skills and effective communication skills.
- Strong presentation, facilitation, and project management skills.
This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department.
Primary Job Location: Milwaukee Design Center
Additional Locations (if applicable): Hays KS Branch
Job Title: Senior Quality Engineer
Company: Agiliti
Location City: Wauwatosa
Location State: Wisconsin
Pay Range for All Locations Listed: $86,563.26 - $160,372.03
This range represents the low and high ends of the Agiliti pay range for this position. This base pay range information is based on the market locations shown. The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors.
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