ABOUT US Orchid Orthopedic Solutions is world leading Medical Device Contract Design and Manufacturing company that offers a comprehensive portfolio of services for implants and instruments with significant experiencein the joint reconstruction, spine, trauma, dental and sports medicine markets. Established in 2005 with a roll-up of best-in-class medical device suppliers with 120 employees. This site specializes primarily in Swiss style turning (straight flute cutting tools and bone& plate screws). We are also FDA registered and ISO 13485 certified. A career with Orchid provides training and growth opportunities, great benefits, including quarterly bonuses, insurance, 401(k) with company match, paid time off and employee engagement events. For more information, please visit www.orchid-ortho.com. SHIFT
No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer, Sustaining Product Quality supports the ongoing quality of Orchid's products. Responsible for providing advanced quality planning and ongoing engineering support. Effectively disseminate customer requirements and generate controls to meet those requirements. Works with engineers, supervisors, managers, production personnel, suppliers and customers to help resolve quality issues, achieve team objectives, and promote quality principles. WHAT YOU WILL DO Provides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.
Uses quality tools to suggest and 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).
Aids in the determination of machine and/or process capability through planning and/or executing Process Capability studies
Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging.
Interfaces with appropriate customer contacts to clarify customer requirements
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 support
Performs quality reviews and internal audits; evaluates data and writes associated reports
Recommends 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 with minimal assistance.
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 Associates of Science (A.S) (Preferred)Bachelor of Science (B.S) (Preferred) EXPERIENCE QUALIFICATIONS No previous work experience required (Required)2+ Years of Experience in a Manufacturing Environment (Preferred)Experience in Medical Device Manufacturing (Preferred)CMM basic knowledge 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 - Basic KnowledgeProduction Part Approval Process (PPAP) - Basic KnowledgeProduction Runs - Working ExperienceFinal Inspection - Basic KnowledgeComputer Knowledge - Working ExperienceProblem Solving - Working ExperiencePHYSICAL DEMANDS Must be able to remain in a stationary position -Must be able to move about the inside of the building -Must be able to move equipment around the building -Must be able to ascend/descend stairs or ladders -Must be able to position oneself and move under/around/over equipment -Must be able to handle/adjust/inspect/position various items and equipment -Must be able to communicate and exchange information with others -Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment -Must be able to distinguish and detect information such as writing and defects -Must be able to move equipment -PAY RATE For positions located in California, pay for this job type falls within the following range and varies based on scope and complexity of job responsibilities.
$69,200.00 - $96,200.00WHAT 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 matterADDITIONAL 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 eVerifyAt 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.
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