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Associate Manager

StrykerCarrigtohill, Cork

Job Description JOB TITLE Associate Manager, Quality Assurance  REPORTS TO Manager/ Senior Manager, Quality Assurance POSITION SUMMARY As leader of a dedicated Quality Operations team for a site/area, provide direction in quality assurance within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Has responsibility for delivering the compliance and business objectives of the function, with primary responsibility to drive engagement and lead the quality team, while ensuring compliance to Stryker Corporate and SGS requirements, Quality System Regulations and standards. KEY AREAS OF RESPONSIBILITY Will work within the Quality Operations structure, in a management capacity, has responsibility for quality related activities which includes, but not limited to the following: • Leads Quality Engineering Team to provide support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality.  • Supports and aligns with the site commitment to ensure the organisation’s conformance to producing products meeting or exceeding customer requirements and the relevant regulatory standards. • Fosters a positive employee relations environment by promoting open communication, engagement and development of team members. Promotes a culture of inclusiveness, trust, flexibility and teamwork. • Create a highly talented team by sourcing, hiring, and placing individuals in positions that play to their strengths and future potential • Drive an environment of compliance within Stryker by working with all function managers and their support staff to define expected quality standards and the roles/responsibilities in the maintenance of these standards. • Participates in ensuring the site(s) maintains continued certification to all regulatory bodies. Plays a lead role in all internal and external audit programmes such as Corporate, notified body & FDA audits. • Ensures effective control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Assesses product & patient risk. • Supports the planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management • Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators, and takes timely action to address adverse trends and deviations. Continuously monitors and partakes in global forums to assess opportunities for improvement. • Assist in developing and supports local and global strategies for the Quality Operations function. QUALIFICATIONS KNOWLEDGE SKILLS • Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage.  • Minimum of 6 years experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment. • Experience of successfully creating and managing a talented, engaged and performing team is advantageous. • Ability to implement organisation and functional strategy. Ability to initiate and implement change with a demonstrated track record (at individual level or team level) • Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies. • Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools. • Must be able to work in a team & individual environments, interacting effectively at all levels, and across all functions with ability to develop organisational relationship and build trust. • Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency at all times. • The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines. Demonstrated Initiative. Work From Home: Not availableTravel Percentage: 10%

15 days ago

Senior Research Engineer

StrykerCarrigtohill, Cork

Job Description Drives Product and/or Process Innovation. Provides input and support on new technology developments and implementation to Research and Development and Process Development teams. Is responsible for planning and executing engineering aspects of new technology Projects occasionally leading and training team members on technical aspects of product commercialization. Work From Home: OccasionalTravel Percentage: 20%

15 days ago

Sr. Staff Engineer

StrykerCarrigtohill, CorkPermanent

Job Description Senior Staff Engineer - Value Engineering Role: Permanent Location: Cork Value Engineering: The function of the Value Engineering organisation is to unlock Value within our current and future product portfolios. The team members will be developing and implementing a range of agile tools to carry out and report on this activity. The team will work with our global partners to complete in-depth analysis of products to build out Should-Cost and Design-to-Value models to drive engineering and business excellence. Senior Staff Engineer What we need! Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. As a Senior Staff Engineer you will contribute a strategic input into the functional strategy and be a champion of operations excellence across the site. You will benchmark best practices across the Stryker network and plans and conduct engineering research design. You will also plans and conduct significant engineering and lean initiatives. You will provide technical leadership to Staff engineers, senior engineers, Engineers, Coop Students, Technicians and operators as required. Work From Home: Not availableTravel Percentage: Up to 25%

15 days ago

Senior Engineer

StrykerCarrigtohill, Cork

Job Description Your key responsibilities #LI-CP Work From Home: NoTravel Percentage: Up to 25%

15 days ago

Ra Compliance Specialist

StrykerCarrigtohill, Cork

Job Description Work From Home: Not availableTravel Percentage: 0%

15 days ago

Mechanical Design Engineer

StrykerCarrigtohill, Cork

Job Description Job Title Design Engineer Reports To Associate Manager Product Engineering Position Summary Designs, develops, refines and evaluates mechanical components assemblies or subsystems for electro-mechanical medical devices. Uses concurrent engineering and rapid prototyping techniques to reduce product time whilst adhering to deadlines and product costs. Provide post market design and product application support for a wide range of medical devices, performing engineering analysis and providing product expertise to Operations and QA/RA teams for reliability improvement, risk management, cost reduction and CAPA activities Execute product development projects and work on technical aspects of product commercialization Key Areas of Responsibility Work From Home: Not availableTravel Percentage: None

15 days ago

Senior Staff Product Development Engineer

StrykerCarrigtohill, Cork

Job Description Senior Staff Product Development Engineer, Cork Role Summary: If you are interested in this exciting opportunity please apply in confidence #LI-EN Work From Home: NoTravel Percentage: 20%

15 days ago

Senior Npi Engineer

StrykerCarrigtohill, Cork

Job Description Senior NPI Engineer, Stryker, Cork Areas of responsibility: Work From Home: NoTravel Percentage: None

15 days ago

Co-op Intern

StrykerCarrigtohill, CorkInternship

Job Description This position provides the Co-Op Student, as part of their college studies, the experience of working in a regulated medical device company. The Co-Op Student undertakes a project that is of mutual benefit to the company and to the student’s practical and academic learning Work From Home: Not availableTravel Percentage: None

15 days ago

Senior Reliability Engineer

StrykerCork, Cork

Job Description What You Will Do: The successful candidate will be part of our Reliability Engineering team and be located in our Tullagreen facility in Carrigtwohill, Co. Cork. You will conduct investigations on customer complaints leading to the identification of root cause and corrective/preventive actions. As a key member of the Reliability Engineering team you will be responsible for meeting and exceeding team and individual KPI's, metrics and targets. You are expected to contribute to the positive team environment and to the continued high levels of engagement within the team. There will be great opportunities for career progression and development. Who We Want: #LI-FOC Work From Home: Not availableTravel Percentage: Up to 25%

15 days ago
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