
Senior Quality Systems Manager
2 weeks ago
The primary function of this role is to lead and supervise a group of Quality Engineers, including Senior Quality Engineer(s), Quality Engineers, and Complaint Investigator(s).
Objectives are agreed upon, training plans are generated, team members are coached, performance appraisals are conducted, and performance-related issues are addressed.
Workload for the group is assessed, and tasks are allocated accordingly.
- Drive all assigned Quality Engineering projects, ensuring they are managed in a structured fashion and completed in compliance with relevant procedures.
- Manage project activities to ensure timely completion of project milestones.
- Represent the team at key review meetings.
- Collaborate with other functions, particularly Operations, IT, Engineering, and Regulatory teams, to build effective relationships.
- Lead the area of FDA, QSR, and ISO13485 requirements, promoting awareness of best industry practice and making informed decisions on a daily basis using a quality manager as the final arbitrator on critical quality decisions.
- Identify opportunities for improvement and implement them.
- Maintain a proactive approach to developing a quality system to meet changing business needs.
- Ensure that in-house or external quality issues are effectively prioritized and addressed in a timely manner.
- Responsible for quality systems, including Design, Process, and Software Validation, Supplier Quality, CAPA, Non-conformances, Customer Complaints, Internal Audit, Supplier Audit, and Regulatory Audit Programmes.
- Trending and analysis of key quality metrics, and responsible for assessing risk throughout quality engineering key processes and systems.
- Provide leadership and mentoring to team members to ensure effective completion of activities associated with their role.
The successful candidate will receive a competitive salary package, including bonuses and benefits. They will also have access to ongoing training and development opportunities, enabling them to enhance their skills and knowledge in quality engineering.
OthersThis role requires strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams. The successful candidate will be based in [location], with regular travel to other sites as required.
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