Position Summary
Quality Lead for all phases of product realization including NPD, NPI, Commercialization, Sustaining and End of Life.
Bring creative, innovative and sound Quality decision making to the team, ensuring effective implementation of the required QMS documentation, and professional communication with all stakeholders.
Provide quality oversight on problems of diverse scope including complaint & NC investigations, selecting methods and techniques for obtaining solutions, driving corrective actions & verifying effectiveness for the assigned area.
Oversee QA inspection, testing & release.
Guides, supports and trains other quality team members.
Principal Responsibilities
Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
Trouble-shoot quality issues identified during product development and commercialization and drive solutions to reduce non-conformances.
Provide quality input and guidance on validation planning and documentation, utilising risk-based (pFMEA) decision-making and driving risk mitigation activities into process development and product quality assurance.
Lead vendor and part appraisal and approval processes.
Lead process change and related assessment and implementation of change notification.
Work with project team in the identification and implementation of appropriate statistical techniques and visual control systems to monitor manufacturing processes.
Ensure that appropriate quality plans, test methods, test plans, deviations, work instructions, specifications and drawings are in place and adhered to during product development, manufacturing transfer and commercialization.
Understand and lead specification reviews, factoring in Teleflex capabilities, and drive alignment with customer on acceptance criteria ensuring Teleflex and customer specifications/drawings are aligned.
Ensure all design/specification/process changes are in line with customer contractual agreements and product safety while facilitating progressive and efficient change management.
Oversee product testing and release activities, including disposition of non-conforming material, identification of scope, control of related NC material, root cause and appropriate CAPA actions, and thorough documentation within schedule.
Establish and monitor process quality performance to determine when improvement actions are appropriate.
Act as key driver in responding to and acting on customer quality feedback and requests.
QE review and sign off on QMS documentation and records.
Participate or lead cross-functional project teams to eliminate waste and improve performance.
Develop and implement programmes to ensure compliance with regulatory requirements and documented controls and procedures within area of responsibility.
Provide support for internal, customer and regulatory audits.
Ensure full compliance with regulatory requirements.
Ensure Quality and EHS policies and procedures are adhered to at all times.
Work on projects as assigned.
Education / Experience Requirements
Degree in an engineering/quality or related discipline.
Certified QE desirable.
Technical report writing.
Process validations/FMEAs and protocols.
Specialized Skills / Other Requirements
A seasoned, experienced professional with full working knowledge of EN ISO *****, principles of GMP, FDA QSR 21 CFR Part 820.
Proficient in statistical analysis.
Structured problem-solving techniques – Lean Six Sigma Green Belt desirable.
Understanding of Lean principles.
Ability to drive projects to completion.
Guided by the disciplines of due diligence and compliance in all aspects of work.
Working Environment
Office.
Equal Opportunity Statement
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.
Diversity & Inclusion
Diversity fosters innovative thinking and entrepreneurship, and that is what we are about at Teleflex.
We trust and value our people and their diversity and we make it fun to work here.
We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in.
We embrace everyone and want them to feel they belong, building a culture where all employees can bring their best and unique selves to the workplace.
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