Quality Engineer, Sustaining Product Quality

Quality Engineer, Sustaining Product Quality

ABOUT US

Orchid Orthopedic Solutions provides solutions for orthopedic implant procedures enabling a longer, active life. Working in an industry that has the ability to impact lives in such a profound way has proved to be a strong motivator for Orchid. The Lansing facility specializes in the forging and machining of hip and knee implants across our 3 campus. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, insurance, 401(k) with company match and paid time off. For more information, please visit www.orchid-ortho.com

SHIFT

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

• Perform visual and/or cosmetic inspection of product following applicable procedure(s) using appropriate light sources. Monitor equipment to ensure proper operation and escalate any equipment-related issues.
• Back up the Quality Documentation Coordinator on Regulatory Release activities per FDA 21 CFR 820.80 (d) when required.

• 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 requirements
• Determines 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.
• 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.
• 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).
• Is a designated member of the Complaint Handling Unit.

EDUCATION QUALIFICATIONS

• Bachelor of Science (B.S) (Required)

EXPERIENCE QUALIFICATIONS

• 3+ Years of Experience (Required)
• 3+ Years of Experience in a Manufacturing Environment (Required)
• Experience in Medical Device Manufacturing (Preferred)

LICENSES AND CERTIFICATIONS

• Any Quality Certification (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Operational Functions - Working Experience
• Quality Management - Working Experience
• Process Management - Working Experience
• Communication - Basic Knowledge
• Accuracy and Attention to Detail - Working Experience
• Manufacturing Safety - Working Experience
• Lean Manufacturing - Working Experience
• Statistical Analysis and Measurement - Working Experience
• Production Part Approval Process (PPAP) - Working Experience
• Production Runs - Extensive Experience
• Final Inspection - Working Experience
• Computer Knowledge - Working Experience
• Problem Solving - Working Experience

PHYSICAL DEMANDS

• Must be able to remain in a stationary position - Frequently
• Must be able to move about the inside of the building - Occasionally
• Must be able to move equipment around the building - Occasionally
• Must be able to position oneself and move under/around/over equipment - Occasionally
• Must be able to communicate and exchange information with others - Frequently
• Must be able to distinguish and detect information such as writing and defects - Frequently

WORKING CONDITIONS

• Noise - Occasionally

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

ADDITIONAL REQUIREMENTS

• 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

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.