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For your reference, we have included the original job posting below.
Sr. Advanced Quality Assurance Engineer
Job Number:
43892468
Company Name:
Stryker Corporation
Job Location:
Phoenix, AZ US
Job Category:
Engineering & Architecture
Sr. Advanced Quality Assurance Engineer
The Senior Advanced Quality Assurance Engineer is co-responsible (with the assigned R&D Project Manager) for the flawless transfer to production and ramp up of new products. Responsible for developing, applying, revising, and maintaining quality standards for new product development process.
This includes: Capture a high level of product and process knowledge uncovered during the design cycle and ensure that knowledge is transferred to the Sustaining Engineering teams in order to facilitate continuous improvement during the product life cycle. Determine or develop appropriate QA deliverables during each phase of the Design and Development Process. Responsible for ensuring adequate research is conducted to ensure that there is adequate control of the device/ process design in order to ensure that the specified specifications are met to satisfy the device intended use and user needs. Plan and implement actions to ensure that all quality deliverables are completed according to the project timeline. Participates in Design Reviews and Risk Management activities to determine adequacy of designs and test activities and recommend improvements. Perform reviews of Verification and Validation protocols to ensure that regulatory and technical/functional requirements are fully satisfied. Prevent delays to projects and excess expenditure of resources by providing thorough, practicable, and creative solutions to difficult problems. Leverage a wide application of principles, theories and concepts in quality science and fundamental engineering disciplines. Apply appropriate statistical and analytical techniques to problems, and provide assistance to other engineers in the use of these techniques. Mentor and coach other engineers and technicians.
Qualifications/Work Experience
Product and Process Design: Support R&D in throughout the New Product Development process: including design and development planning, design inputs and output verification/ validation and design review. Apply Advanced Quality Tools, which includes (but is not limited to): Design for Manufacturability, design for Six Sigma, design for SPC, FMEA, QFD, DoE, Risk Management, Physical Methods, Analytical Methods, Measurement Systems Analysis, as part of new product development teams. Responsible for reviewing Verification and Validation test plans.
Product and Process Control: Develop and implement test methods and equipment.
Quantitative Methods and Tools: Perform complex analyses using appropriate tools.
Goal Setting: Demonstrated self-starter, who is energizing, results oriented and has the ability to drive change across the accepted practices.
-Internal/External Interface: Perform as quality assurance liaison from the Production Tech to VP level for all internal departments (Operations, R&D and Purchasing) regarding overall product quality for assigned product lines and beyond. Interface with sales field (ASR, AM, DM) suppliers, and end customers regarding product quality improvement opportunities and championing the ""Voice of the Customer"" across all departments.
Decision Impact: Erroneous decisions or recommendations can cause serious delays in project/program schedules and/or considerable expenditure and resources.
Decisions/recommendations directly impact the organizations regulatory risk.
Influence /Leadership: Drive results by influence through working in a cross-functional environment.
Demonstrate the positive behaviors that reflect understanding and support of organizational values set forth in the Stryker Sustainability Solutions Mission Statement. Maintain the company quality program in accordance with all applicable federal regulations.
Actively contribute to the company philosophy of providing quality service by treating all individuals with courtesy and sensitivity.
Enhance teamwork by showing a willingness to be flexible in responding to the challenges facing the health care industry.
Manage time and resources effectively through good organizational skills and positive problem solving.
Continuously strive to improve quality of the department, the company in general, and the services the company provides its customers by recognizing opportunities for improvement and ideas that would fall within Ascent goals and objectives.
Participate in creating a professional, friendly environment by maintaining a professional appearance and demeanor.
Education and/or Special Training
-Bachelors Degree: Technical degree from an accredited college or university. An advanced degree is a plus.
-Minimum 5 years engineering experience or equivalent. Previous medical device industry experience preferred, and best industry practice for compliance.
-Knowledge of ISO 13485-2003, 21 CFR 820, and sterilization standards (i.e. ISO 11135) preferred.
-Six Sigma Green Belt and/or CQE preferred.
-Strong written and verbal communication skills. Good knowledge of computers and standard office software. Strong, working knowledge of current FDA and ISO requirements as they relate to Medical Device manufacturing. Strong interpersonal skills, with the ability to work effectively in a team. Should also be able to form and lead a team, as necessary. High ethical standards.
