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NPI Staff Quality Engineer in Salt Lake City, UT at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

Job Description

The Salt Lake City Stryker manufacturing site is experiencing phenomenal growth.  We pride ourselves on our new state of the art facility where we create amazing medical device products. We also have a nationally renowned “hands-on” medical device physician training center. 

We invite you to join our diverse workforce where you can take advantage of flexible work arrangements, outstanding benefits, ping pong table, spectacular mountain views, and our employee fitness center—we even have a climbing wall!  And this is all within a short drive from the airport or downtown!

We create multiple products that treat stroke patients and these state-of-the art devices save lives.  You will work with people here who value integrity, accountability, performance & people.  

Why Stryker?  “It’s the people.” That’s the answer you’ll hear most often when you ask our employees why they love working here. Come join our team in Utah at Stryker!”



What You Will Do

You will provide quality assurance support for all aspects of NPI (new product introductions) including; Supplier Quality Management, Design Control, Incoming /In-process control, Risk Management and NonConformances and CAPA's. You will 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. You will also

Design Control  

  • 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

Process Control  

  • 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

Compliance  

  • 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

  • 4+ years in 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:

  • ISO 13485 and ISO 14971
  • Industrial statistical techniques
  • 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
  • Familiarity with the Quality System Regulation 21 CFR Part 820, and CGMP
  • Experience with Design for Manufacturing
  • Manufacturing Experience
  • Knowledge of Poke Yoke (Error-Proofing) techniques
  • Human Error Prevention and/or Reduction techniques
  • New Product development/R&D experience
  • Experience participating and providing support during third party audits such as TUV, FDA
  • Familiarity with FDA guidelines on Process Validation and Control
  • Conducting Supplier Audits
  • Familiarity with GHTF/SG3/N17:2008 Supplier Management Guidance


 Required Education and Training:

  • B.S. in Engineering, engineering related discipline or equivalent experience
  • Master’s degree in relevant field desired
  • ASQ-CQE, CQA or equivalent course work / experience desired

Work From Home: No

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.

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