Quality Technician II

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance 

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. 

Advancing possibilities for a brighter tomorrow 

We are seeking a Quality Technician II on a permanent basis to join our team. 

Job Purpose: 

Provides technical assistance to engineering to support product development (Axonics) and manufacturing efforts by implementing corrective and preventative actions and managing nonconforming product. Assists engineers in developing methods and procedures to establish, control and improve manufacturing processes.

Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Hours:

2 cycle shift, days and evenings:

Key Responsibilities: 

• Assists Quality Engineering and cross-functional teams in supporting process development during new product introduction by providing input to traceability and inspection requirements, providing input for statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications.
• Uses analytical skills, technical knowledge and procedures / processes to problem solve; evaluates, selects and implement the most appropriate solutions from options determined.
• Helps to develop and implement process improvements by assisting Engineering in researching and validating changes in processes/equipment.

• Develop, monitor, and report on key quality metrics and performance indicators to identify trends, drive decision-making, and support strategic planning.

• Assists Engineering with qualification and validation studies & reports by collecting, compiling, measuring, organizing and recording data, and by writing procedures. May keep ELNs.
• Train operators on processes and engineering changes, and perform operator certification on-the-job training and Quality Defect Awareness (QDA) roll out.

• Responsible for the final Process Monitor Release for products prior to distribution.
• Disposition non-conforming material by utilizing quality tools and by developing knowledge of manufacturing practices and procedures.

• Conducts audits of manufacturing and related areas to assess compliance with internal procedures; reviews finding to determine compliance risk and systems issues.  Prepare and administer reports of audit findings.

• Assists engineering in providing day to day manufacturing process support by identifying manufacturing issues and trends. May also train operators on basic processes and engineering changes, and perform operator certification on-the-job training and Quality Defect Awareness (QDA) roll out.
• Involved with NCEPs, CAPAs and Work Station Vulnerability Assessments (WSVAs).

Education & Experience: 

• NFQ Higher certificate Level 6 in Engineering Studies, Science, Quality Management or a related subject is required.
• Minimum 2 – 5 years medical device experience required.

• Ability to manage multiple projects and priorities simultaneously, demonstrating strong organizational skills, attention to detail, and the ability to deliver results within tight timelines is a distinct advantage.
• Experience with product development initiatives and familiarity with Windchill is a distinct advantage.
• Demonstrated analytical, communication, attention to detail and organizational skills is a distinct advantage.
• Passionate about quality, innovation, and delivering products that improve patient outcomes.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. 

So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! 

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers 

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 email TalentAcquisitionIre@bsci.com