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Quality Manager

Company: Orchid Orthopedics
Location: Sterling Heights
Posted on: November 23, 2021

Job Description:

SUMMARY OF POSITION
The Quality Manager leads the quality team focused on implementing Orchid's Product Quality and EH&S strategy at Orchid's Farmington Hills, MI site to ensure we sustain the quality of existing products and business at that site.

The Quality Manager develops the team of quality professionals and is a key member of the site leadership team. He/she reports to the Director, Quality, Midwest US with an indirect reporting relationship to the site Plant Manager.

SHIFT
No Shift ($0) (United States of America)

WHAT YOU WILL DO

  • Lead, develop and manage full quality team at the site to successfully meet and exceed the essential requirements, goals and results.
  • Develop team members following the One Orchid global talent management approach to select, manage, and develop our best team. Ensure the growth of the Orchid positive business culture through behaviors that align with our core values and leadership competencies.
  • Ensure team members have the required knowledge and skills prior to performing job duties independently, including conducting, documenting and evaluating training effectiveness.
  • Collaborate with the New Product Introduction team to support engineers focused on analyzing, developing, and implementing quality standards and processes for new product launches at the site.
  • Ensures that site complies with internal and external requirements and regulations.
  • Ensures all required QMS documentation is completed and accurate. All Quality System documentation is processed and archived appropriately.
  • Manage the day to day operations of the quality system and organization.
  • Ensures timely reporting and analysis of all customer and internal complaints.
  • Manage the Corrective and Preventive Action (CAPA) system and ensures timely and effective action is taken and documented.
  • Develop quality assurance plans (Advanced Product Quality Plans - APQPs) to understand and mitigate risk to our customers by working directly with customers to:
  • Identify critical control points and preventive measures
  • Establish critical limits, monitoring procedures, corrective actions, and verification procedures
  • Monitor plan effectiveness
  • Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence, determining operational and performance qualification; writing and updating quality assurance procedures.
  • Facilitate MRB review and disposition of non-conforming product.
  • Support internal and external audit of the quality systems.
  • Collaborating with other members of the management team to develop new product and engineering designs and manufacturing and training methods.
  • Oversee Quality Control at the site including, in process inspection and measurement, final process inspection and measurement, and quality record review.
  • Formulate, document and maintain quality control standards and on-going site quality control objectives.
  • Assists the development of essential QMS deliverables including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation.
  • Participate in pre- and post-production reviews.
  • Oversee documentation of current process parameters and instructions to eliminate unnecessary process variations.
  • Monitor and analyze key performance metrics and report them to the site leadership team and corporate Quality groups. Achieve quality assurance operational objectives by serving as the appointed management representative and developing and monitoring appropriate site specific quality metrics to meet company objectives. Follow-up on corporate quality KPIs and ensures appropriate measures are taken and communicated to reach/exceed set KPIs.
  • Add customer value by developing procedures and providing leadership to cross functional teams, formal problem solving (including true root cause analysis), PDCA, and statistical analysis to reduce variation, built in quality, etc.
  • Provide guidance and coaching on problem solving and the proper use of Product Quality Tools.
  • Lead quality and compliance by utilizing One Orchid global processes and complying with all Quality Management Systems (QMS) documentation requirements and establishing/supporting plan(s) to meet/exceed Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.
  • Promote a proactive, cooperative attitude towards issues of environment, health and safety.

    WHAT WE ARE LOOKING FOR

    WORK EXPERIENCE
    2+ Years of experience in a leadership position in a manufacturing environment (Required), Experience in a FDA regulated environment (Required), Experience in Medical Device Manufacturing (Preferred)

    EDUCATION
    Bachelor - Quality Assurance, , Bachelor of Science (B.S) - Engineering, Bachelor Required

    CERTIFICATIONS
    None - ---

    KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
    Blueprint Reading (Extensive Experience), Communication (Extensive Experience), Decision Making and Critical Thinking (Extensive Experience), GD&T (Extensive Experience), Manufacturing Regulatory Environment (Working Experience), Performance Management and Development (Extensive Experience), Problem Solving (Extensive Experience), QSR and ISO (Extensive Experience), Quality Inspection Metrology Tools (Working Experience), Quality Management (Working Experience), Statistical Analysis and Measurement (Extensive Experience)

    WHAT WE OFFER
    • Opportunity to work in a growing company
    • Ability to help people live a longer, more active life
    • Comprehensive benefit package
    • Ability to work in an organization that values:
      • Integrity First: We do the right thing
      • Teamwork: We are one Orchid
      • Results: Our results matter

        PHYSICAL REQUIREMENTS

        Frequently operates a computer.

        ADDITIONAL REQUIREMENTS
        • Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
        • Candidates must be able to provide proof of eligibility to work in the United States through eVerify

          EOE, including disability/vets

Keywords: Orchid Orthopedics, Royal Oak , Quality Manager, Executive , Sterling Heights, Michigan

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