Quality Assurance Specialist
4 days ago
Company Overview
Opto Recruitment is a leading recruitment agency specializing in medical equipment manufacturing.
Job Description
The Quality Engineer will be responsible for supporting all Quality aspects impacting the successful functioning of the manufacturing facility. This includes developing and implementing solutions to sustain and improve the QMS, maintaining and supporting compliance to ISO 13485 and ISO 14001 systems standards, and interfacing with customers on new products and quality issues.
Required Skills and Qualifications
- Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
- 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 an Injection moulding or medical manufacturing environment.
Duties and Responsibilities
- Developing and implementing process control programs to ensure customer requirements are met.
- Carrying out process validations and qualification on products.
- Providing manufacturing support and Quality expertise in relation to Manufacturing issues and product disposition.
- Performing quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
- Co-ordinating NCR / CAPA Process to ensure timely resolution and closure of issues.
- Leading 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.
- Trending and tracking of quality data to support quality improvements across the business.
- Supporting Environmental, Health and Safety requirements, training, and regulations.
- Performing additional duties at the request of the direct supervisor.
Benefits
- Mid-senior level position offering opportunities for career growth and development.
- Full-time employment with a reputable company in the medical equipment manufacturing industry.
- Job function: Medical Equipment Manufacturing.
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