Position Summary
Quality leader to drive BU and Internal programs, systems development and improvement activities relating to the operation of the Quality Management System.
Key responsibilities will include (but are not limited) to the following
Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements
Manage, support and monitor the CAPA process
Lead, drive and monitor effectiveness of the Internal audit process
Manage and host Customer and regulatory audits
Site project leader for the OEM business QMS projects as required
Site system owner of Electronic QMS, maintain current, validated and configured to meet business needs
Site quality technical lead for software approval / Information System projects as required
Preparation of monthly and management review data metrics on Quality System and Quality performance (e.g., Complaints, NCs, CAPA, Audits, supplier performance)
Designate Management Representative in the absence of the Quality Manager as required
Establish and implement Quality compliance programs
Drive performance and process improvements across the Quality Management System and take initiatives to make things better every day
Lead, motivate and develop self and team to meet performance and growth objectives
Develop and cascade departmental long-term and short-term business objectives, in line with business needs
Lead, motivate and mentor cross-functional teams to ensure that project milestones and results are achieved in line with business needs
Work with other departments to facilitate professional and timely delivery of information relating to quality, regulatory, Customer and other queries as they arise
Monitor and drive compliance to GMP and the requirements of the QMS
Drive quality system improvement projects as directed
Ensure full compliance with regulatory requirements
Ensure Quality and EHS policies and procedures are always adhered to
Education / Experience Requirements
Degree in Engineering/Quality, Life Sciences, or a related business technical field essential
Min 5 Years' experience in Quality Systems Management in the FDA 21 CFR 820, ISO *****, regulated Medical Device /Component Industry
Certified QE, desirable
Technical report writing skill
Strong negotiation and problem-solving skills
Auditing knowledge and ability (i.e., Lead assessor certified desirable)
Strong reasoning/analytical skills including the ability to support and prioritize projects and adapt to shifting priorities
Working knowledge of Risk Management and validation principles, in particular software validation GAMP5
Previous experience of managing project teams desirable
Planning and Organisation skills – Project and programme oversight, sponsorship and management
Specialized Skills / Other Requirements
People
Performance Management of others
Coaching and mentoring
Employee Development
Excellent Written and Verbal Communications
A positive attitude in dealing with people
Proven ability to lead and give direction to team members on all aspects of Quality Systems
Ability to lead meetings
Ability to operate and communicate effectively with multiple teams
Display high levels of emotional intelligence
Display qualities and principles of genuine leadership
Work with minimal supervision
Able to successfully resolve problems and conflicts
Customer and Vendors
Ability to generate appropriate relationships with customers, regulators, and leadership
Ability to deal with difficult customer communications
Teleflex is an equal opportunity employer.
Applicants will be considered without regard to age, gender, race, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.
If you require accommodation to apply for a position, please contact us at ******.
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