About this role
ABOUT US
The Farmington Hills, MI site was established in 2005. Our 50,000 square foot facility employs approximately 150 team members. Our site focuses primarily on plasma spray coating (HA, TPS) in the spine and large joint for orthopedic implants that enable a longer, active life. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, medical benefits, 401(k) with company match, and paid time off. For more information, please visit www.orchid-ortho.com.
SHIFT
No Shift ($0) (United States of America)
A BRIEF OVERVIEW The Quality Engineer II supports the ongoing quality of Orchid's legacy products and works with project management and manufacturing engineers to support new production introduction and ongoing validation.
WHAT YOU WILL DO
Completes all required training.Uses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.Acts as a customer liaison and processes customer quality complaints, as applicable.Collects, Analyzes, and Presents data using statistical methodology Assists suppliers with the interpretation of quality requirements, as applicable. Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Interfaces with appropriate customer contacts to clarify customer requirementsDetermines machine and/or process capability through planning and/or executing Process Capability studiesDevelops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging. Conceives and/or Leads productivity improvements and/or Continuous improvement projects Monitors engineering production processes and products for adherence to internal and external requirements and practices. Participates in pre- and post-production launch reviews providing quality engineering supportPerforms quality reviews and internal audits; evaluates data and writes associated reportsRecommends modifications to existing quality or production standards, where applicable, to achieve optimum quality within limits of equipment capability.Reviews and approves product/process and document change requests. Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques. Supports measuring and analyzing key metrics to monitor performance. Works with cross-functional teams to solve production and quality problems. Reinforces safety expectations. Ensures safety operating practices are demonstrated. Reports issues/concerns to Supervisor.Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS). EDUCATION QUALIFICATIONS
Bachelor (Required)Bachelor of Science (B.S) (Preferred) EXPERIENCE QUALIFICATIONS
3+ Years of Experience (Required)3+ Years of Experience in a Manufacturing Environment (Preferred)Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS
Any Quality Certification (Preferred) KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
Operational Functions - Working ExperienceQuality Management - Working ExperienceProcess Management - Working ExperienceCommunication - Basic KnowledgeAccuracy and Attention to Detail - Working ExperienceManufacturing Safety - Working ExperienceLean Manufacturing - Working ExperienceStatistical Analysis and Measurement - Working ExperienceProduction Part Approval Process (PPAP) - Working ExperienceProduction Runs - Extensive ExperienceFinal Inspection - Working ExperienceComputer Knowledge - Working ExperienceProblem Solving - Working Experience PHYSICAL DEMANDS
Must be able to remain in a stationary position - FrequentlyMust be able to move about the inside of the building - OccasionallyMust be able to move equipment around the building - OccasionallyMust be able to position oneself and move under/around/over equipment - OccasionallyMust be able to communicate and exchange information with others - FrequentlyMust be able to distinguish and detect information such as writing and defects - Frequently WORKING CONDITIONS
Noise - Occasionally CURRENT VERSION: 5
WHAT WE OFFER
Opportunity to work in a growing companyAbility to help people live a longer, more active lifeComprehensive benefit packageAbility to work in an organization that values:Integrity First: We do the right thingTeamwork: We are one OrchidResults: Our results matter
ADDITIONAL REQUIREMENTS
Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirementsCandidates must be able to provide proof of eligibility to work in the United States through eVerify
At Orchid, we fully support a diverse and inclusive workplace and we are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability.
Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.