Sr. Staff NPI Quality Engineer in Redmond, WA at Stryker Corporation

发布日期: 5/26/2019

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职位描述

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 imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

As a Senior Staff NPI Quality Engineer, you will 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.

Design Control

  • Ensure proper linkage between Production Control – Process Control – Design output – Design input – Customer Need during Design and Process Transfer.
  • Ensure product specification, material specification, and process specification are fully defined, unambiguous, and practical in production environment. 
  • Create Inspection documents, Test Methods and conduct Test Method validation.
  • Support the development and implementation of inspection strategies and plans for NPI projects.
  • Lead / Support supplied component/product qualification activities.
  • Support the identification, development, auditing, and onboarding of new suppliers during NPI phase to ensure compliance and business continuity.

Process Control

  • Provide process validation support, and lead as required in characterizing, and establishing process window and process control. Understand the process in question from a technical perspective. 
  • Develop and provide input to process validation protocols, contribute to inspections/tests and analysis of the results.
  • Support the creation of process validation plan, protocol and the execution and report generation of process validation (IQ/OQ/PQ).
  • Advocate of Human Factor practices.
  • Conduct knowledge transfer activities by training quality assurance engineers and inspectors.
  • Support the development of process control and process monitoring to assure effectiveness of process transfer.
  • Support quality activities during Post Launch Monitoring as required.
  • Lead investigation and on-time closure of non-conformances, corrective & preventive actions internally and at suppliers related to New Product Development.
  • Create process risk documentation and ensure all Risk Management outputs comply with ISO 14971 for Regulatory Submissions. 
  • Evaluate process risks and ensures appropriate production and process controls are identified, qualified and implemented throughout the product manufacturing lifecycle.
  • Support maintenance of process controls to ensure ongoing product compliance. 
  • Collaborates with SME on all process validation activities to ensure consistent, repeatable and effective processes are implemented during design/manufacturing transfer. 
  • Develop statistical rationale for testing, validation sample size, duration, and number of runs.
  • Ensure worst-case scenarios are challenged during the process development and/or validation. 
  • Supports the development of sterilization validation strategies and collaborates with SME on the execution and documentation of such validation activities. 

Production Control

  • Support the creation of Device Master Records.
  • Support the training of Engineer and operator during production process transfer.
  • Monitor production process.
  • Maintain production change control.
  • Quality System Compliance
  • Promote and drive customer centric quality culture.
  • Monitor and enforce quality activities.

Compliance

  • Continuously fully comply with all quality regulatory requirements.
  • Support internal and external audits. 
  • Commit to environmental policy.
  • Train others in quality assurance/GMP related topics
  • Quality System Compliance
  • Promote and drive customer centric quality culture.
  • Monitor and enforce quality activities.

What you need

  • Bachelor’s Degree in engineering
  • Minimum 8 + years in Quality Assurance or related functional area such as Design/Manufacturing Transfer in medical device or other regulated industry.
  • Preferred Qualifications:
  • 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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