Job Overview
This is a 12‑month onsite contract in Limerick with full Stryker benefits.
Responsibilities
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 and manage internal and supplier‑driven non‑conformances and ensure timely closure of NCs.
Support and/or own internal CAPAs and manage timely root‑cause investigation, implementation, and closure.
Disposition non‑conforming product within MRB and issue NCs as appropriate.
Communicate with suppliers regarding non‑conformances and escalated corrective actions.
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 the creation and/or review of new or modified procedures.
Maintain KPIs for monitoring process and product quality, perform analysis, and interpret trends to activate appropriate actions.
Support execution and analysis of manufacturing‑related complaints and product field actions.
Advocate Human Factor practices, applying the science of human‑factor identification, reduction, and mitigation.
Collaborate with stakeholders to identify and execute opportunities for supplier part certification.
Develop understanding of risk‑management concepts and apply knowledge to manufacturing operations.
Support the creation and maintenance of inspection methods and sampling plans.
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 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.
Requirements & Qualifications
Level 8 Degree in Science or Engineering.
0‑2 years (or up to 2 years) experience in Quality or a related field.
Previous industry experience desired.
Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred.
Understanding of US and international medical device regulations.
Familiarity with ISO 13485, GDP, GMP.
Strong knowledge of Quality concepts: risk management, CAPA, audits, statistics.
Strong communication, project‑management, and influencing skills.
Strong interpersonal, written, oral, and negotiation skills.
Strong critical thinking and outside‑the‑box thinking.
Highly developed problem‑solving and analytical skills.
Demonstrated ability to work independently and as part of cross‑functional teams.
Experience in a compliance‑risk situation.
Computer literacy.
Some travel may be required.
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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