Stryker NPI Quality Engineer in Salt Lake City, Utah
Requisition ID 26928BR
Job Title NPI Quality Engineer
Group Global Quality and Ops
Division SGS Quality Assurance
Business Unit QA NA West
Business Function Quality Assurance
Country United States
City Salt Lake City
Employment Category Full Time
Percent Travel Required Up to 10%
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 All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by applicable law. We are an EO employer – M/F/Veteran/Disability.
Job Description / Information
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.
Basic Function :
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.).
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.
- Build productive and collaborative internal/external professional relationships across Design Divisions & GQO functions associated with design transfer activities.
4 years minimum 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
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, others.
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.
All 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