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Director of Quality

Job Description

.Acara Solutions (formerly Superior Group) is helping our medical device client find a Senior level quality manager in Eugene, OR that has a strong history in the medical device arena. This is a direct hire salaried positionActual title of position: Head of QualityBe a strong Quality leader, integrate and transform all aspects of quality for medical and non medical devices comprised of hardware and software, and software only. Improve performance; integrate fast growing businesses in a corporate structure, enable market launches and rapid expansion. For this you will need state of the art quality systems, engineering, assurance, compliance and medical and non medical product quality domain knowledge. Extraordinary leadership and influencing skills required.You: Are the main interface between the Quality functions and business management. You facilitate meeting goals in a compliant manner and you understand how quality policies and business processes interact. You work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, Supply Chain and Marketing & Sales.Responsible for:
  • Lead QMS integration and improvement in a recently acquired medical device business in the organization.
  • Handle budget and timeliness.
  • Lead and coach a growing Q team.
  • Ensure all medical and non medical products and services align with all applicable regulations, standards, and policies.
  • Ensure Quality & Regulatory aspects are adequately covered in the selection, control and monitoring of suppliers.
  • Responsible for all aspects of quality throughout the entire product lifecycle.
  • Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement.
  • Collaborate with Business and Q&R Management to establish strategic plans and objectives
  • Establish, track and report quality objectives throughout the entire enterprise
  • Job Requirements

    .Required Skills / Qualifications:
    • Min 7 years of experience in a quality management role (hands-on leader, leading by example, coaching and teaching the Quality team).
    • Min 5 years of experience being responsible for compliance of the Quality Management System (QMS) with relevant standards and regulations.
    • Min 5 years of experience in quality management within the medical device industry
    • Min 5 years of experience setting up and maintaining compliant Quality Management Systems
    • Min 2 years of experience with design controls in Software Development environment
    • Approximately 25% travel
    Preferred Skills / Qualifications:
    • Experience with manufacturing quality control is a strong preference.
    • Consistent record as a change leader is a strong preference.
    • Practical knowledge of medical European and US standards and regulations is a strong preference
    • Consistent track record in integration of corporate quality systems is a plus.
    • Excellent verbal and written communication skills (English)
    • Strong communication and influencing skills
    Go Beyond. www.superiorjobs.com.
    EEO Employer - Minorities / Females / Disabled / Veterans / Sexual Orientation / Gender Identity.

    Job Snapshot

    Location US-OR-Eugene
    Employment Type Full-Time
    Pay Type Year
    Pay Rate N/A
    Store Type Engineering
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    Company Overview

    Acara Solutions

    Acara understands that finding that rewarding next step along your career path can be challenging. We also understand the legwork that goes into being your career advocate. Our award-winning recruiters focus on the candidate experience, getting to know you and your goals, both long- and short-term. They get to know your skills and your growth trajectory so that they not only can represent you in front of our more than 1,000 customers with opportunities across North America, but also connect you with the best-fit role. After all, optimal workforce experiences come when employees are matched with companies who need—and value—their skills and contributions. Learn More

    Contact Information

    US-OR-Eugene
    Angela Walker
    Snapshot
    Acara Solutions
    Company:
    US-OR-Eugene
    Location:
    Full-Time
    Employment Type:
    Year
    Pay Type:
    N/A
    Pay Rate:
    Engineering
    Store Type:

    Job Description

    .Acara Solutions (formerly Superior Group) is helping our medical device client find a Senior level quality manager in Eugene, OR that has a strong history in the medical device arena. This is a direct hire salaried positionActual title of position: Head of QualityBe a strong Quality leader, integrate and transform all aspects of quality for medical and non medical devices comprised of hardware and software, and software only. Improve performance; integrate fast growing businesses in a corporate structure, enable market launches and rapid expansion. For this you will need state of the art quality systems, engineering, assurance, compliance and medical and non medical product quality domain knowledge. Extraordinary leadership and influencing skills required.You: Are the main interface between the Quality functions and business management. You facilitate meeting goals in a compliant manner and you understand how quality policies and business processes interact. You work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, Supply Chain and Marketing & Sales.Responsible for:
  • Lead QMS integration and improvement in a recently acquired medical device business in the organization.
  • Handle budget and timeliness.
  • Lead and coach a growing Q team.
  • Ensure all medical and non medical products and services align with all applicable regulations, standards, and policies.
  • Ensure Quality & Regulatory aspects are adequately covered in the selection, control and monitoring of suppliers.
  • Responsible for all aspects of quality throughout the entire product lifecycle.
  • Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement.
  • Collaborate with Business and Q&R Management to establish strategic plans and objectives
  • Establish, track and report quality objectives throughout the entire enterprise
  • Job Requirements

    .Required Skills / Qualifications:
    • Min 7 years of experience in a quality management role (hands-on leader, leading by example, coaching and teaching the Quality team).
    • Min 5 years of experience being responsible for compliance of the Quality Management System (QMS) with relevant standards and regulations.
    • Min 5 years of experience in quality management within the medical device industry
    • Min 5 years of experience setting up and maintaining compliant Quality Management Systems
    • Min 2 years of experience with design controls in Software Development environment
    • Approximately 25% travel
    Preferred Skills / Qualifications:
    • Experience with manufacturing quality control is a strong preference.
    • Consistent record as a change leader is a strong preference.
    • Practical knowledge of medical European and US standards and regulations is a strong preference
    • Consistent track record in integration of corporate quality systems is a plus.
    • Excellent verbal and written communication skills (English)
    • Strong communication and influencing skills
    Go Beyond. www.superiorjobs.com.
    EEO Employer - Minorities / Females / Disabled / Veterans / Sexual Orientation / Gender Identity.
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