דרושים Associate Quality Director ב-Boston Scientific ב-Ireland, Cork

Job Purpose

In Operations, provide daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety). In New Product Development and Sustaining Engineering, support the development and advancement of product design deliverables for next generation and already commercialized products.

Key Responsibilities

• Build Quality into all aspects of work by maintaining compliance to all quality requirements.

• Assists to define and implement all Quality standards and specifications and helps to ensure that Corporate and Regulatory requirements are met

• Identifies and resolves moderately complex exceptions to work assignments

• May participate directly in a new product/technology transfer to gain the necessary experience/exposure which such a challenge presents.

• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.

• Will be broadly conversant with validation techniques and associated Regulatory requirements including analysis of customer feedback and complaints.

• Understands and proactively follow through on the Environmental Management.

• Actively interacts with cross-functional team members, always practicing good teamwork, in support of day-to-day operating requirements.

• Demonstrates best practices in line with the department and site objectives.

Education & Experience

• NFQ Level 8 Honours Bachelor’s degree in a STEM discipline is required. (You must be graduating prior to September 2026 or have graduated in last 2 years)

• An understanding of systems and a willingness to learn and develop technical skills.

• Good communication skills, teamwork abilities and initiative.

• Proven ability to work well as part of a team & on own with minimum supervision.

• Eager to learn and active participate.

• Strong interpersonal skills.

• Eligible to work in Ireland.

• Competitive Benefits –we offer market leading benefits including performance-related bonus, pension contribution, onsite gym, onsite parking, subsidised canteen, organised social groups and healthcare.

• – opportunity to transform the lives of patients worldwide.

• - our work is guided by core values that define our culture and empower our employees.

• Career Development– our highly engaged leaders will empower you to grow and will invest in your potential. You can also broaden your skills through personal development courses.

• – we encourage you to fulfil your true creative potential by speaking up with your ideas and solutions to problems that matter.

• – we have created a culture that acknowledges, respects and supports your life and work choices.

• Corporate Social Responsibility– we are dedicated to progressing business practices in areas important to our communities. Our onsite charity events have raised over €1.5 million for worthy causes in the past ten years.

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Job Purpose:

role. Sterilization operates in a 24/7 shift pattern (12-hour shift).

Note Job shifts:

Day1 Mon to Wed (7AM to 7PM), alternating Sunday

Day2 Thurs to Sat (7AM to 7PM), alternating Sunday

Nights1 Sun to Tues (7pm to 7AM), alternating Saturday

Nights2 Wed to Fri (7PM to 7AM), alternating Saturday

Responsibilities:

• Work with Line Facilitators to manage the process, the process loads and Production Area.
• Work with Manufacturing Engineers in developing, trouble shooting, standardising and improving existing production methods and procedures.
• Work with Engineering team to commission and validate new sterilization equipment.
• Support and assist on equipment and cycle qualifications and validations.
• Proactive on PSPI and PDCA in the area.
• Work on Electronic/ Mechanical troubleshooting and electronic hardware interfacing.
• Investigate and implement new production methods.
• Interface with a variety of BSI personnel and with outside vendors when necessary while performing the above.
• Take responsibility for preventative maintenance procedures with an assigned process or area.
• Assists in implementing technical improvements under the teams C.I. program.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their manager.
• Owns the key performance metrics for the ME function.

Qualifications and Experience

• HETAC NFQ Level 6 Honors Degree in STEM
• Sterilization experiences an advantage.
• Strong focus on safety and safety procedure adherence.
• Strong electromechanical experience required.
• Plant equipment experience an advantage.
• Electrical level 2 or 2+ years relevant years experience required
• Comfortable working with full PPE (respiratory gear etc) – requirement to be clean shaven
• Experience with Gas cylinders an advantage
• Drives continuous improvement efforts
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well both as part of a team but also able to work on own with minimum supervision

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Job Purpose:

To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.

Key Responsibilities:

• Be the Subject Matter Experts with regard to Acceptable Quality Standards for products and processes.
• Ensure Regulatory compliance in area to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
• Represent QA as the first point of contact for daily line support issues.
• Troubleshoot product and process related issues and identifies root cause.
• Be an agile team member who can support all functions required based on shift requirements.
• Complete investigation of customer complaints.
• Work with QE’s and product teams to identify areas for risk reduction and error proofing processes and work on implementation of these.
• Drive Defect awareness training with product builders with the assistance of the manufacturing trainer.
• MRB: Provide disposition for any non-conforming product and identify appropriate corrective action with other support team members.
• Participate in internal quality audits.
• Trending and analysis of key Quality metrics.

Education & Experience:

• NFQ Level 6 or above in Science or Engineering Discipline.
• 2-5 Years experience in a similar position or medical device background.
• Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required.
• Learning ability, to learn an automated process and be comfortable to support on shift as required.
• Good interpersonal, planning & prioritising and communication skills are required for this role.

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Responsibilities Include:

• Establishes, develops, and maintains positive business relationships with Customers and Patients.
• Provides clinical support in surgeries, troubleshooting and follow ups in hospitals and clinics.
• Uses clinical expertise, market & product knowledge to advance growth opportunities.
• Provides exceptional customer service to all customers.
• Educates customers staff on technical matters relating to Axonics products and therapies.
• Completes proper Patient care documentation in Axonics Patient Care Management (PCM) system.
• Makes and receive patient calls/text through Axonics PCM system. Some calls can be after hours and weekends.
• Partners with Area Director and Territory Managers to learn market dynamics and local customer motivations and needs; has a thorough understanding of how Axonics products and solutions offer value to the patient.
• Contributes to the achievement of quarterly goals associated with specific initiatives at the Area and / or on a national level.
• Assists with education / training of new employees.
• Manages inventory provided for case coverage and trunk stock.
• Expedites the resolution of customer problems and complaints to maximize satisfaction.
• Coordinates sales and marketing efforts with team members and other departments.
• Visits accounts regularly to replenish literature and establishes / maintains relationships with office staff.
• Works closely with Territory Managers to drive sales growth in target accounts and key areas.
• Actively participates in territory sales growth activities such as but not limited to customer lunch and learns, community education sessions, Advance Practitioner seminars, quarterly business reviews and other approved activities.
• Supplies management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
• Keeps abreast of best practices and promotional trends.
• Maintains high level of clinical, market and product knowledge.
• Completes all assigned training in a timely manner.
• Continuously improves through feedback.
• Manage personal expenses per company expense policy and report monthly in Concur.
• Maintains proper credentials for Hospital Systems in area.

Qualifications:

• Bachelor’s degree preferred.
• A minimum of 3 years of clinical experience in the medical device industry or a minimum of 5 years of clinical experience in urology as a RN.
• Highly motivated and target driven with a proven track record.
• Excellent communication and negotiation skills.
• Prioritizing, time management and organizational skills.
• Ability to create and deliver presentations tailored to the audience needs.
• Relationship management skills and openness to feedback.

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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Key Responsibilities

• Drive and implement process improvements to ensure predictable processes across shipping and boxpack processes (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
• Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
• Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Approval of change requests for product, process and quality system changes.
• Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
• Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.

Education & Experience

• Minimum of Bachelor of Science Degree in Engineering/Technology.
• 3/4 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
• Experience in the medical device industry is an advantage.

To search and apply for open positions, visit:

Advancing possibilities for a brighter tomorrow

To search and apply for open positions, visit: