Engineer, Quality Assurance (12 months FTC)
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 and lead initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards.
Key Areas of Responsibility
Work closely with operations and business functions to ensure quality performance of product and processes.
Collaborate with Divisional QA, cross‑functional and supplier teams to address top quality issues.
Own identified internal and supplier‑driven non‑conformances and manage timely closure.
Own or support identified internal CAPAs and manage to timely root‑cause investigation, implementation and closure.
Disposition non‑conforming product within MRB, issuing NCs as appropriate.
Communicate 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.
Perform critical assessment of internal and supplier proposed change management activities.
Participate in 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 appropriate actions as necessary.
Support execution and analysis of manufacturing related complaints and product field actions.
Advocate 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 apply knowledge to manufacturing operations.
Support the creation and maintenance of inspection methods and sampling.
Apply 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 qualification/validation 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.
Qualifications (Knowledge, Skills)
BSc / B. Eng. in a science, engineering or related discipline preferred, or equivalent years of experience.
0+ years experience in a manufacturing environment or equivalent.
Knowledge of Quality Concepts (Risk Management, CAPA, Audits, Statistics).
Strong communication and project management, ability to influence without authority.
Ability to manage multiple tasks simultaneously and work independently or as part of cross‑functional teams.
Strong interpersonal skills, written, oral communication and negotiation skills.
Strong analytical and problem‑solving skills.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
Computer literacy.
Some travel may be required.
Preferred
BS in a science, engineering or related discipline.
Minimum of 10 years experience, 7 years supervisory experience.
Masters Degree or equivalent.
Experience working in a regulated environment.
Good understanding of manufacturing process technologies, and ability to understand complex processes.
Experience delivering results through Six Sigma and lean methods.
Strong analytical ability, relevant ERP knowledge (preferably SAP, Oracle or JDEdwards) and strong PC skills (MS Excel, Access, etc.).
Company and Equal‑Opportunity Statement
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.
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