Quality Engineer

4 weeks ago

Athlone, County Westmeath, Ireland Solventum Full time
Overview

Join to apply for the Quality Engineer (m/f/x)* role at Solventum.

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. Solventum is at the heart of every innovation we pursue, guided by empathy, insight, and clinical intelligence. All listed roles are Solventum positions. Our Privacy Policy applies to any personal information you submit. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Responsibilities
  • Initiate and complete technical activities and cost savings as part of process improvements, including updates to risk documentation, procedures, test methods, and process/software validation, with significant business impact.
  • Initiate, review, and approve change controls.
  • Perform, analyze, and interpret statistical data using statistical tools and methods.
  • Develop strategy and implement appropriate sampling methods.
  • Write and review CAPAs, NC/NCMRs and SCARs to address compliance issues and provide guidance to suppliers and engineering teams.
  • Ensure compliance for Product Manufacturing, Packaging and Labeling.
  • Perform Internal and Supplier Audits.
  • Support and participate in external regulatory body audits (e.g., ISO and FDA).
  • Create and analyze data for Quality Metrics.
  • Comply with required training and maintain associated documentation.
  • Adhere to Environmental, Health and Safety (EHS) policies and related documentation.
  • Follow CGMP requirements.
  • Actively contribute to the enhancement of compliance initiatives within the role's responsibilities.
Your Skills And Expertise

To set you up for success, Solventum requires (at a minimum) the following qualifications:

  • Education: Degree in Engineering or Science related field.

In addition to the above requirements, the following are also required:

  • Experience: Three (3) years of experience in a regulated environment (medical device, FDA or ISO 13485) is preferable.

Additional qualifications that could help you succeed include:

  • Strong computer skills (MS Excel, PowerPoint, Word, etc.).
  • Familiarity with statistical tools (Pareto charts, trend charts).
  • Familiarity with FMEA and root cause analysis tools.
  • Experience with problem-solving techniques.
  • Ability to communicate technical information effectively to both non-technical and technical colleagues.
Work Details

Work location: Athlone, Ireland

Work Type: Hybrid Eligible (some remote work possible; travel to Athlone at least 3 days per week)

Travel: Flexible and available to support business needs as required.

Important Notices

The information listed is not a comprehensive list of duties and responsibilities and does not constitute a contract. Management may alter this description at any time. Applicants must be legally authorized to work without sponsorship where required.

Solventum is an equal opportunity employer. Diversity and inclusion are valued. Be aware of fraudulent postings and ensure communications come from an @solventum.com domain.

Please note: your application may not be considered if you do not provide education and work history information (via resume upload or direct entry).


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