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Stryker New Product Introduction Staff Quality Engineer in Salt Lake City, Utah

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a New Product Introduction Staff Quality Engineer located in Salt Lake City, Utah

Who we want:

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do:

  • Provide quality assurance support for all aspects of New Product Introductions including; Supplier Quality Management, Design Control, Incoming /In-process control, Risk Management and NC/CAPA. Focus on establishing long-term strategies for Quality, Risk Management, Inspection & testing and Suppliers for new product introductions in order to sustain product competitiveness while maintaining compliance to domestic and international regulations and standards.

  • Ensure the integrity of design control elements in Design Transfer including VOC Translation and Control, Design Input / Output validity, and completeness of DIOVV

  • Support the design/manufacture transfer process to ensure compliance with the current design control, transfer regulations and policy

  • Support the development of material specification and incoming inspection process

  • Select, develop and qualify suppliers

  • Support process development, process characterization and establishment of process window.

  • Capture process knowledge to facilitate subsequent validation activities

  • Support Process monitoring to ensure ongoing product compliance

  • Responsible for the identification of potential failure modes, risks, and controls

  • Develop quality assurance practices for New Product Development Projects and/or Manufacturing Transfers

  • Apply lean six sigma concepts, practices, and procedures of the advanced quality specialization (i.e. PDCA, DMAIC etc.)

  • Production Control

  • Ensure the efficient and timely transfer of Process knowledge, and Quality systems knowledge to Ops Quality

  • Coordinate the training of Quality Engineers and related personnel on new quality systems and equipment

  • Support the creation of production documents and quality records for new products

  • Oversight and approval of new products related NC’s & CAPAs

  • Support and mentor problem solving and root cause analysis activities

  • Drive a customer centric quality culture and maintain compliance to regulation and internal quality system

  • Implement quality systems while achieving product performance and quality objectives

  • Ensure that customer and regulatory requirements are incorporated into the product / process

  • Support audit preparation strategy and execution. Participate and interface with internal & external audits with regulatory representatives

  • Inter-organization Collaboration

  • Build productive and collaborative internal/external professional relationships across Design Divisions & GQO functions associated with design transfer activities

What you need:

  • B.S. in Engineering or related discipline

  • Master’s degree in relevant field desired

  • 5 pus years’ experience

  • Experience with Quality Assurance or related functional area such as Design Transfer/Manufacturing Transfer; preferably in medical device, or other regulated industry

The following experiences/skill sets are highly desirable:

  • ASQ-CQE, CQA or equivalent course work / experience

  • ISO 13485 and ISO 14971

  • Development and implementation of design and process controls (i.e. PDCA, DMAIC experience)

  • Geometry Dimensioning & Tolerancing

  • Six Sigma Black Belt Certification preferred

  • Experience with SPC

  • Familiarity with FDA Guidance on Design Controls and CAPA Methodologies, 21 CFR Part 820

  • Experience with Design for Manufacturing

  • Manufacturing Experience

  • Human Error Prevention and/or Reduction techniques

  • New Product development/R&D experience

  • Familiarity with FDA guidelines on Process Validation and Control

Work From Home: Not available

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com