Job Title: Quality Engineering Group Lead
Our company is seeking an experienced Quality Engineer to lead our Quality Engineering group. The primary function of this role is to supervise and manage the Quality Engineering team, including Senior Quality Engineers and Quality Engineers.
The successful candidate will have proven knowledge and experience in working with ISO 13485, ISO 14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and FDA QSR, including 21 CFR Part 820 and 21 CFR Part 11.
Responsibilities:
* Lead and supervise the Quality Engineering group
* Agree objectives and generate training plans for team members
* Coach team members and conduct performance appraisals
* Assess workload for the group and allocate tasks accordingly
* Represent the team at key review meetings
* Manage and drive project activities to ensure timely completion of project milestones
* Work closely with other functions to build effective relationships
Required Skills and Qualifications:
* Third-level qualification in Science, Engineering or relevant technical discipline
* Proven knowledge and experience in working with quality systems and regulations
* Excellent communication and interpersonal skills
* Proven track record of pursuing continuous self-improvement
* Good working knowledge of Microsoft Office and statistics
Benefits:
* Opportunity to work on challenging projects
* Collaborative and dynamic work environment
* Professional development opportunities
Others:
* Responsible for Quality systems including Design, Process and Software Validation
* Responsible for Supplier Quality, CAPA and Non conformances
* Designee for the Quality Engineering Manager