Senior Engineer, Quality in Fremont, CA at Stryker Corporation

Date Posted: 8/1/2018

Job Snapshot

  • Employee Type:
  • Location:
    Fremont, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

In this position, you will develop, establish and maintain quality engineering methodologies, systems, and practices which meet Stryker, customer, and regulatory requirements.  You will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives supporting departmental, functional, site, divisional and corporate quality goals and priorities.  You will provide focused quality engineering support within new product development, operational, and system/services.

Additionally, you will...

  • Demonstrate a primary commitment to patient safety, product quality and compliance with the Stryker Quality Manual and its governing regulations.
  • Provide a leadership role in championing departmental or cross-functional engineering initiatives.
  • Provide project direction, coaching, and mentoring for engineering and technical team personnel.
  • Investigate, identify, and implement best-in-class Quality Engineering practices.
  • Provide technical guidance mentoring for identifying and resolving quality issues.
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Act as an effective leader/team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Develop and execute streamlined business systems which effectively identify and resolve quality issues.
  • Conduct qualification, verification, and validation activities.
  • Perform sterilization validation/re-validation activities & processes.
  • Release product for distribution.
  • Complete complaint investigation activities and coordinate reporting of results and trends.
  • Participate in external Quality System audits
  • Conduct activities, tasks, and documentation per quality system requirements.
  • Develop and conduct production environmental monitoring programs to ensure that the manufacturing environment is adequate to make product that will meet requirements.
  • Supervise manufacturing inspections and auditing.
  • Participate in developing team settings, as assigned.
  • Coordinate and report on the product complaint system.
  • Assist with MDR & Vigilance reporting to appropriate regulatory officials.
  • Conduct specialty testing for shape-memory Nitinol material.
  • Evaluate non-conformances and implement appropriate corrective actions.
  • Coordinate calibration activities of Quality System.
  • Conduct work in and maintain a clean, safe, health conscious work area.
  • Conduct other tasks and responsibilities, as requested.
  • Support PDP process for new Products.
  • Supplier Quality Engineering – Vendor Qualification and performance monitoring.

If you have these basic qualifications:

  • BS degree in Engineering or related discipline.
  • 5+ years Quality Engineering experience or equivalent education / experience, with at least 1 year experience within medical device industry or other regulated manufacturing environment (i.e., biotech, pharma, aerospace).

We want to talk to you!  

And if you have these preferred qualifications:

  • ASQ Certified Quality Engineer.
  • Strong written/verbal communication skills. 
  • Demonstrated use of Quality tools/methodologies.
  • Ability to work well with others in a team setting.
  • Ability to conduct statistical, geometric, and mathematical calculations.
  • Ability to conduct responsibilities substantially free from routine supervision.
  • Ability to read and understand engineering drawings.

We really want to talk to you! Apply now...

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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