Company: Orchid Orthopedics
Location: Sterling Heights
Posted on: November 23, 2021
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.
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
- 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
- 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
- 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
- Manage the day to day operations of the quality system and
- Ensures timely reporting and analysis of all customer and
- 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
- Facilitate MRB review and disposition of non-conforming
- Support internal and external audit of the quality
- Collaborating with other members of the management team to
develop new product and engineering designs and manufacturing and
- 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
- 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
- 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
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
Bachelor - Quality Assurance, , Bachelor of Science (B.S) -
Engineering, Bachelor Required
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
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
Frequently operates a computer.
- 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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