Quality Manager

Advanced Medical Solutions Group plc; United Kingdom; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the medical device industry is seeking a Quality Manager to oversee the site quality function in Plymouth, UK. This role involves managing a team to ensure compliance with quality standards and driving continuous improvement of the quality management system. The ideal candidate will possess a scientific background with leadership experience and proficiency in quality regulations.

Qualifications

• 4+ years experience in medical device or pharmaceutical industries.
• Knowledge of Medical Device regulation.
• Ability to manage multiple projects effectively.

Responsibilities

• Managing the site quality team including quality systems and quality engineering.
• Driving quality improvement projects and supporting regulatory compliance.
• Ensuring Quality Management System certification and continuous improvements.

Skills

Leadership

Quality System Regulations

Communication

Problem-solving

Statistical Analysis

Education

BSc or equivalent in a scientific discipline

Tools

Excel

Word

PowerPoint

Job description

Social network you want to login/join with:

Job Details

To provide leadership to the site quality function. To manage successful delivery of the Quality Strategy to deliver the corporate goals and objectives. To assure necessary compliance requirements through the Quality Management System including continuous improvements, CAPA management, document management, quality planning, internal and external audits, validation, risk management, and continuous Quality Management Review. To define clear quality objectives and goals for the site quality team.

Act as site Quality lead to ensure the quality system complies with applicable requirements of cGMP, MDSAP regulations, and Medical Device regulation (MDR).

To support site operations, ensuring compliance while achieving continuous improvement and development of the quality management system across AMS Group.

Key Responsibilities

This role involves:

1. Managing the site quality team at Plymouth, including quality systems, quality engineering, and QC where required.
2. Supporting the maintenance and improvement of the site quality management system to comply with MDR and MDSAP regulations and Group procedures.
3. Driving the successful execution and implementation of applicable Quality strategies.
4. Ensuring the site Quality team is well trained and motivated.
5. Preparing and managing the budget for the site quality function.
6. Acting as site Management representative, where required.
7. Establishing and managing quality improvement projects as part of the site Operations management team.
8. Supporting effective delivery of new product development, ensuring quality deliverables comply with design control and validation requirements.
9. Maintaining quality management system certification.
10. Continuously improving the Quality management system.
11. Making decisions related to quality issues, including root cause analysis and corrective actions to prevent product recalls.

Candidate Requirements

• BSc or equivalent in a scientific discipline or equivalent experience (minimum 4+ years) in medical device or pharmaceutical industries.
• Leadership experience in previous roles.
• Proficiency in applicable Quality System Regulations and ISO quality standards.
• Knowledge of Medical Device regulation.
• Proficiency in QA, Manufacturing, Validation, Change Control, and Design Control processes.
• Proficiency with spreadsheets and word processing applications.
• Knowledge of statistics, sampling plans, and statistical analysis.
• Experience with analytical methods, equipment, process, software, cleaning, and validation.
• Ability to independently plan, execute, and problem-solve moderate to complex situations.
• Good judgment within policies and procedures for solution methods and techniques.
• Strong oral and written communication skills.
• Ability to manage multiple projects effectively.
• Proficiency with Word, PowerPoint, and Excel for report generation and data analysis.

Employment Basis: Full Time

Location: Plymouth, United Kingdom

Applications Close Date: 27 Sep 2024