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Sr. Supplier Quality Engineer
2 months ago
Job Title: Sr. Supplier Quality Engineer
Job Location: Milwaukee Wisconsin 53215
Onsite Requirements:
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.
3+ years of experience leading supplier quality management and new product development projects
Job Description:
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.
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
** 3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply.
This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future.
This client is a US Federal Government contractor and is legally required to hire US Citizens. US Citizens will only be considered for this role.
Due to the nature of the work, a United States Government Clearance is required to be eligible for the position **
