Quality Coordinator

Adelphi Group; Haywards Heath; Hybrid; GBP 42,000 - 52,000; Full time

Benefits offered by this job

EV salary sacrifice car

Pension contributions

Job summary

The Adelphi Group is seeking a Quality Coordinator to join our Quality team, supporting the ISO 9001 and ISO 13485 Quality Management Systems. This role offers the opportunity to broaden knowledge across quality systems, auditing, supplier management, investigations and regulatory compliance.

Based in Haywards Heath, the role provides clear progression within Quality and involves collaborating with multiple stakeholders to sustain and drive continuous improvement in a highly regulated

Qualifications

• 5+ years in a Quality Management System within a regulated industry.
• Experience with ISO 9001 and ISO 13485 environments.
• Experience managing NCRs, investigations and Change Control.
• Strong document control and quality systems administration.
• Excellent organisational and communication skills.
• Ability to work independently whilst contributing to a team.
• Internal Auditor qualification or auditing experience.
• Experience with CAPA management and supplier quality processes.

Responsibilities

• Maintain ISO 9001 and ISO 13485 Quality Management Systems.
• Manage NCRs, investigations and corrective actions.
• Coordinate Change Control activities from initiation to closure.
• Support CAPA management and effectiveness reviews.
• Control and maintain quality documentation and databases.
• Support supplier qualification and performance evaluation.
• Assist with customer complaints, investigations and trend analysis.
• Participate in internal, supplier and certification body audits.
• Contribute to continuous improvement projects and quality system enhancements.
• Prepare quality metrics, reports and Management Review inputs.
• Provide quality support to operational departments and business improvement initiatives.

Skills

Quality management

Auditing

Change control

Documentation control

Communication skills

Independent working

Education

Internal Auditor qualification

Tools

Microsoft Office

Job description

At The Adelphi Group of Companies we are proud of the products and the high level of services we provide to our customers and understand the importance of our philanthropic activities to give back to the community. We have been a privately owned family organisation for over 75 years, over which time we have acquired multiple businesses and exponentially expanded our product portfolio both domestically and internationally. Our focus is manufacturing and distributing packaging equipment and components, predominately in the highly regulated arena of pharmaceuticals, biotech, diagnostics and sterile products, with expertise in additional market sectors of cosmetics, food & beverage, household products, and lube oil.

Adelphi Healthcare Packaging is a trusted global distributor of high-quality primary packaging solutions serving the pharmaceutical and healthcare industries globally.

The Role

We are seeking an experienced Quality Coordinator to join our Quality team, supporting the maintenance and continuous improvement of our ISO 9001 and ISO 13485 Quality Management Systems.

Our business is approximately 90% focused on healthcare and pharmaceutical distribution activities, with the remaining 10% involving our role as the legal manufacturer of an established Class I sterile medical device manufactured by approved subcontract partners.

Reporting directly to the Head of Quality,this role provides an excellent opportunity for an experienced quality professional to broaden their knowledge across quality systems, auditing, supplier management, investigations, and regulatory compliance, with clear opportunities for future progression within the Quality function.

Key Resposibilities

• Maintain and support the ISO 9001 and ISO 13485 Quality Management Systems.
• Manage and coordinate Non-Conformance Reports (NCRs), investigations, corrective actions and follow-up activities.
• Administer and coordinate Change Control activities from initiation through implementation and closure.
• Support CAPA management and effectiveness reviews.
• Control and maintain quality documentation, SOPs, records and quality databases.
• Support supplier qualification, monitoring and performance evaluation activities.
• Assist with customer complaints, investigations and trend analysis.
• Support internal, supplier, customer and certification body audits.
• Participate in continuous improvement projects and quality system enhancements.
• Prepare quality metrics, reports and Management Review inputs.
• Provide quality support to operational departments and business improvement initiatives.
• Support regulatory and compliance activities associated with the company's medical device operations.

Candidate Requirements

• Minimum 5 years' experience working within a Quality Management System in a regulated industry.
• Experience working within ISO 9001 and/or ISO 13485 environments.
• Demonstrable experience managing NCRs, investigations and Change Control processes.
• Strong document control and quality systems administration experience.
• Excellent organisational and communication skills.
• Ability to work independently whilst contributing effectively as part of a team.

Proficient in Microsoft Office applications.

• Internal Auditor qualification or practical auditing experience.
• Experience participating in customer, supplier and certification body audits.
• Experience within medical device, pharmaceutical, healthcare or regulated distribution industries.
• Experience with CAPA management and root cause investigations.
• Knowledge of supplier quality management processes.

Location: Haywards Heath, West Sussex (On-site)

Reporting to: Head of Quality

What's on offer?

• EV salary sacrifice car option
• Pension Plan contributions

Adelphi is a family owned and managed business since its beginnings in 1947 and this will continueon tothe next generation. This continuity of ownership has promoted a stability that is valued by our suppliers, employees and customers alike. Many of our relationships date back over decades and are built on mutual respect and trust.

The Adelphi Group of Companies is an equal opportunity employer and values diversity.