About Your New Employer:
- You have a chance to work with a leader in medical devices manufacturing.
- Company passionate about changing people's lives.
- Training and development opportunities.
- Great work-life balance.
About Your New Job:
As a Quality Engineer II you will be responsible for:
- Supervision of Quality Technicians.
- Driving and implementing process and quality system improvements.
- Providing effective and responsive QA support to Operations.
- Ensuring all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
- Ensuring Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process and quality system changes.
- Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
- Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- Compilation of required Regulatory documentation.
- MRB: Review of MRB trends and identification of appropriate corrective actions when required.
- Performing internal quality audits.
- Supporting the implementation of Lean Manufacturing across the site.
- Transfer and implement product and processes from development or from another manufacturing facility.
What Skills You Need :
- Minimum of Bachelor of Science Degree in Engineering/Technology
- 2+ years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
What’s on Offer:
- Industry leading package: competitive salary, health care and pension.
- Good work-life balance: sociable hours.
- Fantastic progression opportunities.
- Defined career path.
Hit 'Apply Now' or for a confidential discussion about this please reach out to Jakub on 021 2359 140 or firstname.lastname@example.org
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