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Orchid Orthopedic Solutions Manager, Quality, Full-Site Leadership, Orchid Chelsea (Deputy Management Rep) in Chelsea, Michigan

SUMMARY OF POSITIONThe Manager, Quality, Full Site Leadership leads the quality team focused on implementing Orchid's Product Quality and EH&S strategy at Orchid's Chelsea, Michigan, site to ensure we sustain the quality of existing products and business at that site.

The Manager, Quality, Full Site Leadership and 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.

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.
  • Oversees development of quality assurance plans (e.g., 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
  • Oversees validation of 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 system.
  • Collaborating with other members of the management team to develop new product and engineering designs and manufacturing and training methods.
  • 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.
  • Improve and implement the Productivity Funnel.
  • 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.
  • Communicate regulatory with Technical and Production Managers on quality, schedules, workflow and operations.

WHAT WE ARE LOOKING FOR

WORK EXPERIENCE

5+ Years of Experience Leading Quality in A Regulated Industry (Required), Management/leadership Experience

EDUCATION

Bachelor of Science (B.S): Engineering (Required)

CERTIFICATIONS

CQE, CQA, CQM - ASQ, Lead Auditor - ISO 13485, Lean Manufacturing, Kaizen, 5S - Any

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 (Extensive Experience), Performance Management (Extensive Experience), Problem Solving (Extensive Experience), QSR and ISO (Extensive Experience), Quality Management (Extensive 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 all connected
  • Results: We are all driven

PHYSICAL REQUIREMENTS

  • None

ADDITIONAL REQUIREMENTS

  • Candidates offered employment must submit to a pre-employment background check and pre-employment drug test
  • Candidates must be able to provide proof of eligibility to work in the United States through eVerify

EOE, including disability/vets

Position: Manager, Quality, Full-Site Leadership, Orchid Chelsea (Deputy Management Rep)

Company: Orchid Orthopedic Solutions

Job Location(s): Chelsea, MI

Start Date: As soon as possible

Employment Term: Regular

Employment Type: Full Time

Starting Salary Range: Not Provided

Required Education: Bachelor's Degree

Required Experience: Open

Required Security Clearance: None

Related Categories: Engineering - General, Management and Supervision, Quality Assurance/Safety

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