Senior Quality Engineer

Position Summary

Quality leader to drive BU and Internal programs, systems development and improvement activities relating to the operation of the Quality Management System.

Principal Responsibilities

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, NC’s, CAPA, Audits, supplier performance etc.
•    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 takes 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.
•    Works 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 13485, 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

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