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 initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
What you will do
As a Staff Quality Engineer you will work closely with operations and the business functions to ensure quality performance of product and processes. You will collaborate with Divisional QA, cross functional and suppliers teams to address top quality issues. You will own identified internal and supplier non-conformances and manage the timely closure of NC's.
- 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 internal manufacturing processes for existing products.
- Performs critical assessment of internal and supplier proposed change management activities.
- Performs PPAP activities for supplier changes
- 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, and support of Commercial Holds for potential product escapes.
- Drive continuous improvement actions to reduce manufacturing defects.
- Provide leadership and subject matter expertise in QA activities to the overall site.
What you need
- BS in a science, engineering or related discipline.
- 6+ years' experience
- 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 required.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
Work From Home: NoTravel 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.