Loading...
Share this Job

Quality Engineer - Perm role Job

Apply now »
Apply now

Apply for Job

Date: Jun 26, 2021

Location: Cork, C, IE

Company: Boston Scientific

Additional Locations:

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.

At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion.

Purpose

Act as a member of the Boston Scientific Cork quality team.  To provide expert QA support to the establishment of the Pharmaceutical Quality system and then ongoing support to Operations, in ensuring operational goals and objectives are achieved for the plant. The Quality Engineer will play a key part in establishing and leading performance improvement of both inbound and outbound process by engaging and working with a cross functional team to ensure adequate procedures and processes in place to consistently meet Boston Scientific’s requirements.

 

Responsibilities

  • Own, author, review and/or approve reports, procudures and validation documents in support of establishing pharmaceutical quality system to GMP requirements. 
  • Be the Subject Matter Experts regarding Acceptable Quality Standards and GMP practices for products and processes.
  • Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Participates in determining goals and objectives for projects.
  • Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Evaluate quality events ensuring compliance with cGMP and quality standard requirements. Support root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events. Ensure timely and effective actions are implemented and that CAPA effectiveness checks are conducted.
  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed.
  • Ensure Regulatory compliance in area of responsibility for GMP pharmaceutical regulatory agencies (FDA, HPRA etc.)
  • 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.
  • Approval of change requests for product, process and quality system changes.
  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • 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.

 

Requirements:

 

  • 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
  • Excellent written and verbal communication skills
  • Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
  • Strong command of MS Office – Word, Excel, PowerPoint.
  • Ability to rapidly learn and use new applications

 

 

Requirements:

 

  • 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
  • Excellent written and verbal communication skills
  • Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
  • Strong command of MS Office – Word, Excel, PowerPoint.
  • Ability to rapidly learn and use new applications

 

Perferred Qualifications: 

 

  • Previous experience in a Quality, or Manufacturing background, particularly in relation to pharmaceutical quality systems
  • Experience in the pharmaceutical industry and GMP manufacturing
  • Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated with manufacturing controls.
  • Experience in problem solving and process improvement methodologies
  • Process Validation, Risk Management, CAPA experience.

 

 

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 (NYSE: BSX) 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!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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.

 


Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Engineer, Engineering, Quality, Healthcare