Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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.
Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.
Stryker is hiring a Senior Quality Engineer in Arlington, TN.
This position will be heavily focused on Risk Management principles, pFMEA, utilizing a Risk Based approach for inspection reductions and site level continuous improvement activities within a Medical Device and Biologic Manufacturing environment. Candidate shall be proficient in ISO14971 and ICH Q9 Risk Management standards and guidance.
What you will do:
- 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.
- Mentor and provide technical direction across multiple areas of expertise.
- Ensure compliance to regulation and standards.
- 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 non-conformances and manage the timely closure of nonconformances.
- 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
- 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, 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 will need:
- BS in a science, engineering, or related discipline.
- 4+ years’ experience in quality, engineering, manufacturing and/or operations within a highly regulated industry
- Medical device, pharmaceutical, or biopharmaceutical industry experience preferred
- Experience with ISO14971 and ICHQ9 risk management standards and guidance
- 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).
- 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 within and across 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 successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently and as part of cross-functional teams.
- Experience in working in a compliance risk situation.
- Some travel may be required.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.