• Job Description

  Req#: R506576
  Work Flexibility: Onsite

  Stryker is hiring a Senior Quality Engineer to be located in Ventura, California. This Engineer will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards.

  Stryker Ventura manufactures patient-fitted prostheses for the reconstruction of the temporomandibular joint. Each prosthesis is individually fabricated for the unique anatomy of the patient. Most of our patients have had more than 5 previous surgeries resulting in significant bone loss and distortion to the normal anatomical features. The patient-specific total joint is a PMA approved (US) and custom made (OUS). The Stryker Ventura site has in-house EtO sterilization and over 20+ years of clinical history.

  Workplace Flexibility: Candidate must reside within a commutable distance to the Ventura, CA facility but is expected to be onsite at the facility multiple times/week.

  Who we want:

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

  • Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

  What you will do:

  • Work closely with operations and the business functions to ensure quality performance of product and processes.

  • Collaborates with Divisional QA, cross-functional and suppliers’ teams to address top quality issues.

  • Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.

  • Disposition non-conforming product within MRB, issuing NC's as appropriate.

  • Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.

  • Engage in the development and improvement of the internal manufacturing processes for existing products.

  • Performs critical assessment of internal and supplier proposed change management activities.

  • Performs PPAP activities for supplier changes

  • Participates and may lead in the creation and/or review of new or modified procedures.

  • Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

  • Support execution and analysis of manufacturing related complaints and product field actions.

  • Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.

  • Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.

  • Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.

  • Support the creation and maintenance of inspection methods and sampling.

  • Applies statistical methods of analysis and process control to current operations.

  • Engage and interface in internal and external audits providing subject matter expertise

  • Support the development and review of process and equipment validation/qualification and MSA of internal processes.

  • Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.

  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

  • Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.

  What you will need:

  Required:

  • BS in a science or engineering

  • 2+ years’ experience within the medical device industry and/or manufacturing experience in a highly regulated environment.

  Preferred:

  • 3+ years of experience preferred

  • MS, CQE, or CRE preferred.

  • Six Sigma Green or Black belt preferred.

  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.

  • 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).

  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.

  • Ability to represent Quality function with project teams.

  • Strong interpersonal skills, written, oral communication and negotiations skills.

  • Strong in critical thinking and "outside the box" thinking.

  • Highly developed problem-solving skills. Strong analytical skills.

  • Demonstrated ability to work independently and as part of cross-functional teams.

  • Experience in working in a compliance risk situation.

  $73,100.00 to $152,400.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

  Travel Percentage: 10%

  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.

• About the company

  Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.

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