Quality Specialist Ii
4 weeks ago
To support this companies expansion and growth, we have a great opportunity for a new Quality Specialist II within our Quality team
The role would ideally suit a quality specialist with a background in medical devices, who enjoys working across the full product lifecycle - from product concept through to manufacturing support. The role will include support and maintenance of existing products, and will require strong technical knowledge of quality systems, proficiency in change controls, continuous improvement, risk management, and verification/validation activities.
**Your deliverables will include the following**:
- Monitor and report on all activities, processes, and procedures of the quality management system.
- Assist in the logging, investigation, analysis and documentation of complaints, non-conforming product and CAPA.
- Support Supplier approvals and re-assessments in accordance with planned requirements.
- Create, maintain and evaluate product/process trends, design and participating in process and product changes to improve product quality.
- Contribute to the development of company policies, processes, and procedures.
- Inspection and release of materials, processes, and products (on-site or remote), ensuring compliance with stated requirements.
- Assist in risk assessment activities for relevant processes/products (i.e. dFMEA, pFMEA) ensuring compliance with ISO14971.
- Assist in the validation planning and preparation of processes/products which require validation.
- Support document control activities
- Support QMS training activities.
**What you will need to succeed**
You will be an energetic, passionate, self-starter with a positive disposition and someone who will relish a working environment which is focussed on growth and the changes needed to deliver it.
In addition, we are looking for an individual to display the following capabilities:
- Strong written and verbal communication skills.
- Strong root cause/corrective action skills.
- Strong analytical, problem solving skills.
- Experience of working to quality & regulatory standards including ISO13485.
- Comfortable with dealing with contractors, clients & the regulatory authorities.
- Familiarity with ERP, electronic document control systems, CAPA and training software packages.
- Ability to develop good working relationships with colleagues at all levels of the organisation and perform both independently and as part of a team.
This role will require infrequent travel to local CEM partner so a driving license is required.
**What you’ll get in return**
- Pension: 3% Employers Contribution
- Annual Leave Allowance: 33 days (including bank holidays)
**Salary**: £25,000.00-£35,000.00 per year
**Benefits**:
- Company car
- Company pension
Schedule:
- Monday to Friday
Work Location: In person
Reference ID: QUALSPEC
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