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Senior Quality Engineer
3 months ago
Our Mission:
At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care.
We are seeking a Senior Quality Engineer on a permanent basis to join us on our mission.
Job Purpose
You will demonstrate commitment to the Quality Policy through your daily execution of sound quality practices and the maintenance of an effective quality system and complying with regulations governing the quality system. You will ensure your team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
Key Responsibilities
- Lead a group or team of employees in the achievement of organizational goals.
- Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
- Assure that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establish and promote a work environment which supports the Quality Policy and Quality System.
- Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations.
- Have the responsibility and authority to make decisions related to product quality including the disposition of non-conforming product.
- Demonstrate and actively promote highest level of professional QA Engineering discipline and rigor.
- Be a leader in QSR, ISO / MDD standards within your group, be constantly aware of best industry practices.
- Have significant expertise in validation engineering and be familiar with all regulatory requirements.
- Champion continuous improvement and innovation from a quality perspective within the department.
- Provide technical guidance to Quality Engineer, Associate Quality Engineers and technicians.
- Build quality into all aspects of work by maintaining compliance to all quality requirements.
- Promote the attainment of group goals by selecting, motivating, and training capable staff.
- Monitor progress toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.
- Provide direction and guidance to experienced professional employees.
- Act as an adviser to professional employees and may become actively involved, as required, to meet schedules and resolve problems.
- Evaluate performance of and assist in career development planning for subordinates.
- Work under minimal supervision. Independently determine and develop approach to solutions.
- Create immediate to mid-range plans to carry out objectives established by top management.
- Interview and recruiting new team members as needed.
Education & Experience
- A Bachelor Degree Level 8 (240 credits) of Engineering, Sciences or equivalent experience with a minimum of 8 years experience in a healthcare environment.
- 5-8 years’ Quality Assurance/Engineering experience in the Medial Device / Combination Product (Highly regulated environment)
- Experience with new product introduction and project management is advantageous
- Team player with strong work ethic and positive mentality
- Strong written & verbal communication skills, with excellent stakeholder management.
- Strong technical knowledge & understanding of product design.
- People management experience is advantageous.
At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please let us know.