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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 experience in 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 .
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
EXPERIENCE QUALIFICATIONS
LICENSES AND CERTIFICATIONS
KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
PHYSICAL DEMANDS
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
ADDITIONAL REQUIREMENTS
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.
EOE, including disability/vets.Full Time
Medical Technology
$107k-126k (estimate)
03/12/2024
05/16/2024
orchid-ortho.com
ARAB, AL
1,000 - 3,000
2005
MICHAEL E MILLER
$200M - $500M
Medical Technology
Orchid Orthopedic Solutions is a worldwide leader of medical device outsourcing services, providing expertise in a wide-ranging offer, from design and development through finished goods manufacturing. The company offers a broad array of services and capabilities for orthopedic and medical device development and manufacturing such as Design, Quality Systems, Regulatory Affairs, Implant Manufacturing, Instrument Manufacturing, Sterile and Non-Sterile Packaging. With experience in joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial, orthobiologics, dental, cardiovascular and... general surgical devices, Orchid has the expertise to bring a quality product to market with speed and precision. Orchid is a global company with more than 1,500 skilled employees in major markets around the world. The company provides unparalleled customer service with innovative solutions in the following technologies Advanced Machining Technologies, Forging and Investment Casting, Complex Instrument Manufacture , Cutting Instrument Manufacture, Plastics Technology and Bone Ingrowth Coatings. Orchid specializes in implants, instruments and innovative technologies for the following markets: Orthopedics (Joint reconstruction, Spine, Trauma, Sports Medicine, Extremities), Dental, Minimally Invasive Surgery, Cardiovascular and General Surgical
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The job skills required for Quality Engineer include Analysis, Problem Solving, Product Quality, Test Design, Quality Management, Integrity, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.