Belfast, GBR
22 hours ago
Quality Engineer, Product Assessment Centre
Develops and implements methods and procedures for quality assurance, process control, and preventative activities with a focus on continuous improvement. Designs and installs testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Engages with cross-functional projects to enhance quality performance within the business. Analyses reports and defective products to determine trends and recommend corrective actions. Mentors and provides technical direction. Collaborates with supplier representatives on quality problems and contributes to supplier quality improvement programs. Maintain processes and ensure compliance with relevant laws and regulations. + Analyse customer complaints. + Initiate and lead the development of test methods, tooling, techniques, and procedures for electronic failure analysis on returned product/PCBAs. + Provide technical support and direction in the resolution of technical problems with dedicated test equipment. + Collaborate with suppliers and cross-functional teams to drive quality improvements through NC/CAPA investigations. + Procure new test equipment for PAC laboratory in accordance with team requirements. + Perform preventative maintenance and co-ordinate calibration of PAC laboratory equipment. + Be accountable for local procedures applicable to Customer Quality laboratory, E.g. EPA ESD. + Assure compliance with relevant laws and regulations. + Develop processes and create process documentation in support of the Customer Quality Team. + Provide input by identifying opportunities and weaknesses in current process. + Utilise multiple data sources to make informed conclusions. + Perform risk assessments on customer complaints. + Collaborate with clinical team in the evaluation of patient-involved events to determine root cause. Escalate nonconformances as required. + Support the Corrective Action and Preventive Action (CAPA) process. + Support analysis for Product Field Action activities as required. + Review failure trends and coordinate investigation, analysis, and corrective action. + Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary. + Any other duties deemed necessary by PAC Supervisor, Customer Quality. **Note: This description is not intended to establish a total definition of the job, but an outline of the duties.** **Qualifications/Experience** Candidates should have a Level 6 qualification in an electronic engineering, science, or related discipline **Experience: Essential** Proficient in use of laboratory equipment i.e., oscilloscope, digital multimeter etc Hand soldering experience with SMD components. Excellent verbal and written communication skills, with ability to convey complex or technical information in an effective manner to non-technical staff. Use of basic data analysis tools. Familiarity with Quality Concepts (e.g. Risk Management, CAPA, PFA, Audit). Ability to manage multiple tasks simultaneously. Ability to work independently and as part of cross-functional teams. Ability to represent Customer Quality function within project teams. Analytical and problem-solving skills. Computer literacy with office software applications. **Experience: Desirable** Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.). Understanding of US and International Medical Device Regulations. IPC Qualification Knowledge of ISO 13485, GDP, GMP. **Desirable Competencies:** Commitment - willingness to take ownership of a task or go the extra mile to ensure deadlines or targets are achieved. Conscientious individual demonstrating attention to detail. Flexibility - willingness to adjust to meet the business needs. A team player. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. 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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