The Role:
- Senior Quality Engineer
- Athlone
- Hybrid role with some remote working possible
- Permanent or Contractor Role
The Role:
Reporting to the Quality Manager you will be responsible for supporting all Quality aspects impacting the successful functioning of the manufacturing facility.
Main responsibilities:
- Developing and implementing solutions to sustain and improve the QMS.
- Maintain and support compliance to required regulated systems standards.
- Interface with customers on new products quality issues and process qualifications.
- Develop and implement process control programs to ensure customer requirements are met.
- Carry out process validations and qualification on products.
- Provides manufacturing support and quality expertise in relation to manufacturing issues and product disposition.
- Performing quality engineering analysis to identify strategies to prevent quality nonconformances and minimize risk.
- Coordinate NCMR / CAPA Process to ensure timely resolution and closure of issues.
- Lead training activities on Quality Procedures e.g. Compliance GMP Audit Prep and GDP.
- Supporting and representing the site during external audits and carrying out Internal Audits.
- Supporting Environmental Health and Safety requirements training and regulations.
Skills Brief:
- Third level qualification in Engineering Quality Validation or equivalent Manufacturing experience
- Knowledge of the following from a Quality perspective CAPAs NCMRs Change Controls and SCARs.
- Experience in statistical analysis (Minitab) / SPC / validations.
- Excellent interpersonal communication influencing and facilitation skills
- A minimum of 3 years experience as a Quality Assurance Engineer within medical device or pharmaceutical manufacturing environment.
Person Brief:
- Third level qualification in Engineering Polymer Science Biotech or equivalent Pharma or Medical Device manufacturing experience.
- A minimum of a level 8 Degree qualification
- 2 years experience in a Quality / Validation role in a Pharma or Medical Device manufacturing environment
- Living within a reasonable commute of the Athlone site location and with suitable transport enabling you to be onsite at least 50% of the time.
Opportunity Brief:
This is an excellent opportunity to work with clients who are global leaders in their field helping to develop and improve upon industry leading technology solutions. SL Controls offers a supportive environment committed to employee development and wellness along with a competitive and rounded compensation package which rewards high performers.
Company Brief:
SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers including many of the worlds top multinational companies in the medical device and pharmaceutical sectors achieve their Six Sigma and OEE targets.
Over the past 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway Limerick Leinster and Florida USA.
We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users OEMs and Technology providers.
Find out more about working at SL Controls our Sustainable Development Goals and our Diversity Equity and Inclusion policy.