Quality Engineer (m/f/x)*

Solventum; Athlone; Hybrid; EUR 50,000 - 70,000; Full time

Job summary

A healthcare innovation company in Athlone seeks a Quality Manager to lead quality activities. This hybrid role requires a degree in Engineering or Science and 3+ years of experience in a regulated environment. Responsibilities include process improvements and compliance audits. Strong computer skills and familiarity with statistical analysis are preferred. Join a diverse workplace committed to making healthcare better.

Qualifications

• Three years of experience in a regulated environment, preferably in a medical device setting.

Responsibilities

• Initiating and completing technical activities for process improvements.
• Performing Internal and Supplier Audits.
• Writing up and reviewing CAPAs to address compliance issues.

Skills

Strong computer skills (MS Excel, PowerPoint, Word, etc.)

Familiarity with statistical tools

Experience with problem-solving techniques

Education

Degree in Engineering or Science related field

Tools

Statistical tools

Job description

Overview

At Solventum, we enable better, smarter, safer healthcare to improve lives. We pursue game-changing innovations at the intersection of health, material and data science, and collaborate with healthcare professionals to address customers’ toughest challenges. All listed roles are Solventum positions, and our Privacy Policy applies to any personal information you submit. Solventum is an equal opportunity employer committed to a diverse and inclusive workplace.

The Impact You’ll Make in this Role

As a Quality Manager you will have the opportunity to tap into your curiosity and collaborate with innovative and diverse colleagues worldwide. You will initiate and perform defined quality activities leading to new or improved processes or systems and make an impact by ensuring quality across the organization.

Responsibilities

• Initiating and completing technical activities and cost savings as part of process improvements through updates to risk documentation, procedural updates, test methods, process/software validation, etc., with significant business impact
• Initiating, reviewing, and approving change controls
• Performing, analyzing and interpreting statistical data using statistical tools and methods
• Developing a strategy and implementing appropriate sampling methods
• Writing up and reviewing CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering
• Ensuring compliance is maintained for Product Manufacturing, Packaging and Labeling
• Performing Internal and Supplier Audits
• Supporting and participating in external regulatory body audits (e.g., ISO and FDA)
• Creating and analyzing data for Quality Metrics
• Complying with all relevant training and associated documentation
• Adhering to Environmental, Health and Safety (EHS) policies and documentation
• Following CGMP requirements
• Contributing to enhancements of compliance initiatives within areas of responsibility

Your Skills And Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Education: Degree in Engineering or Science related field
• Experience: Three (3) years of experience in a regulated environment, preferably in a medical device, FDA or ISO 13485 registered setting

Additional qualifications that could help you succeed:

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

Work Details

• Work location: Athlone, Ireland
• Work Type: Hybrid Eligible (some remote work; travel to Athlone at least 3 days per week)
• Travel: Flexible and available to support business needs as required

Additional Information

The information listed above is not a comprehensive list of duties. This job description is not a contract. Management may alter duties at any time. You must be legally authorized to work without sponsorship in the country of employment.

Diversity & Inclusion

We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.

Compliance and Communications

Be mindful of legitimate Solventum communications. Our email domain will be solventum.com. Please provide your education and work history when applying, either by uploading a resume or entering it directly in the application fields.