A BRIEF OVERVIEW
The Senior Quality Engineer is responsible for supporting the ongoing quality of Orchid's legacy products and collaborating with project management and manufacturing engineers to facilitate new production introduction and ongoing validation.
- 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 in the development of essential QMS deliverables/Advanced Product Quality Planning (APQP).
- Plans and/or conducts process and equipment validations and special validations.
- 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.
- 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.
- Reviews and approves product/process and document change requests.
- Supports measuring and analyzing key metrics to monitor performance.
- Works with cross-functional teams to solve production and quality problems.
- Reinforces safety expectations and ensures safety operating practices are demonstrated.
- Supports quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).
EDUCATION QUALIFICATIONS
Bachelor of Science (B.S) (Required)
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 Experience
- Quality Management - Working Experience
- Process Management - Working Experience
- Communication - Basic Knowledge
- Statistical Analysis and Measurement - Working Experience
- Problem Solving - Working Experience
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
- Teamwork
- Results
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 are committed to supporting 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, national origin, age, status as a protected veteran, or disability.