Senior Quality Engineer - Supplier in Fremont, CA at Stryker Corporation

Date Posted: 2/10/2020

Job Snapshot

Job Description

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.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend robust solutions to prevent future issues.
  • Effective communicators. People who can concisely communicate results, expectations, and recommendations to stakeholders, external suppliers, and their teams.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to resolve quality issues, implement effective supplier and engineering changes, and drive continuous improvement.

What you will do

As a Senior Quality Engineer, you will provide support in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes for Original Equipment Manufacturer (OEM) and Contract Manufacturer (CM) suppliers.

You will support supplier quality issues impacting daily operations and internal business units addressing supplier changes, development of suppliers and ensuring that our external supply chains are capable of meeting expectations from a quality, service and cost perspective.

You will advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers, ensuring compliance to regulation and standards.

  • Own and manage internal and supplier driven non-conformances (NCs) and CAPAs, ensuring timely containment actions, corrections, root cause investigation, implementation of corrective actions, and closure. 
  • Perform critical assessment of supplier initiated changes.  Identify required deliverables and partner with suppliers to execute on required PPAP activities.
  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
  • Communicate and collaborate with suppliers regarding supplier non-conformances, escalating supplier corrective action requests as required.
  • Engage in the development and improvement of the supplier's manufacturing processes for existing products.
  • Maintain KPIs for monitoring of process and/or product quality, perform analysis and interpret trends, identifying and activating on appropriate actions as necessary.
  • Support analysis and resolution of supplier manufacturing related complaints and product field actions.
  • Engage and interface in internal and external audits providing subject matter expertise.
  • Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes. 

What you need

  • BS in engineering, science or related discipline.
  • MS, CQE, or CRE preferred.
  • 3 + years of experience
  • Six Sigma Green or Black belt preferred. 
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred.
  • Understanding of US and International Medical Device Regulations.
  • Familiarity with ISO 13485, GDP, GMP desired.
  • Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

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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