Senior Quality Assurance Manager

2 weeks ago

Waterford, Waterford, Ireland beBeeLeadership Full time €80,000 - €110,000
Job Summary

Role Overview:

As a quality leader, you will be responsible for providing strategic direction and governance to ensure the effectiveness of our Quality Management System.

This role involves managing multiple concurrent projects to maintain regulatory compliance throughout the product development lifecycle.

The successful candidate will play a critical part in ensuring product quality and patient safety by executing quality processes effectively.

You will lead efforts to enhance the supply chain by addressing supplier and customer issues, improving quality processes internally and with suppliers, and executing quality strategies.

  1. Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria.
  2. Gain buy-in from project team and ensure an inclusive approach to project planning.
  3. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
  4. Collaborate with cross-functional teams, internal and external to the organization, to coordinate project execution and ensure that project objectives and success criteria are met.
  5. Provide Quality direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements.
  6. Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing batch record reviews, etc.).
  7. Support the development and maintenance of product or process risk and hazard analysis in accordance with organizational policies and procedures and ISO standards.

Key Responsibilities

Project Planning and Execution:

Develop and execute comprehensive project plans, ensuring timely completion and adherence to budget and resource allocations.

Quality Leadership:

Provide strategic direction and governance to ensure the effectiveness of the Quality Management System.

Supply Chain Enhancement:

Lead efforts to improve the supply chain by addressing supplier and customer issues, enhancing quality processes, and executing quality strategies.

Regulatory Compliance:

Maintain regulatory compliance throughout the product development lifecycle, ensuring product and process compliance to all applicable regulatory and cGMP requirements.

Requirements
  • Bachelor's Degree in Engineering or Science or equivalent experience required.
  • Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Manufacturing and Post Market Surveillance Activities required.
  • Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required.
  • In-depth knowledge of cGMP regulations, ISO 15378 or ISO 13485, 21 CFR 820, ISO 14971 required.
Preferred Qualifications
  • Experience with MasterControl, SAP, Share Point.
  • Experience with ISO 11040, ISO 11607.
  • Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
  • Strong working knowledge of quality systems of the respective ISO norms
Additional Requirements
  • Exhibit a strong commitment to quality and patient safety.
  • Ability to work effectively in a fast-paced environment with multiple priorities and deadlines.

  • Senior Quality Assurance Expert

    2 weeks ago

    Waterford, Waterford, Ireland beBeeQuality Full time €90,000 - €110,000

    Job Summary:\We are looking for a skilled Senior Quality Assurance Expert to oversee the execution of proprietary design & development projects.\\Key Responsibilities:\\Ensure that all proprietary design & development projects comply with relevant regulations, regulatory requirements, international standards, and enterprise procedures.\Identify and promote...

  • Quality Assurance Leader

    2 weeks ago

    Waterford, Waterford, Ireland beBeeQuality Full time €69,600 - €87,600

    Job Summary">We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for providing quality assurance support to design and development teams, ensuring compliance with relevant regulations and standards.Key Responsibilities:">Provide quality assurance support to design and development...

  • Senior Quality Manager

    3 hours ago

    Waterford, Waterford, Ireland beBeeQuality Full time €105,000 - €143,000

    Senior Quality Manager Job OverviewThis is a high-profile role that demands exceptional quality assurance skills and experience in project management. As a Senior Quality Manager, you will be responsible for guiding cross-functional teams to ensure the highest standards of quality across all projects.Key ResponsibilitiesQuality Governance: Develop and...

  • Quality Assurance Specialist

    6 hours ago

    Waterford, Waterford, Ireland beBeeQuality Full time €35,000 - €43,500

    Job Title: Quality Assurance SpecialistThe quality assurance specialist plays a pivotal role in maintaining quality excellence across the organization.Key ResponsibilitiesProvide guidance and support on all quality management system activities.Ensure that quality processes meet specified standards and comply with current good manufacturing practice...

  • Quality Assurance Engineer

    14 hours ago

    Waterford, Waterford, Ireland Quanta Consultancy Services Ltd Full time

    Quality Assurance Engineer - Ireland, Waterford Month ContractJoin a high-impact project at the forefront of medical device innovation.Support the design and development of a cutting-edge drug delivery system with a €5 million budget, working in a collaborative environment with the potential for long-term career growth.Responsibilities:Support the...

  • Quality Assurance Engineer

    2 weeks ago

    Waterford, Waterford, Ireland Quanta Consultancy Services Ltd Full time

    Quality Assurance Engineer - Ireland, Waterford - 6-12 Month ContractJoin a high-impact project at the forefront of medical device innovation. Support the design and development of a cutting-edge drug delivery system with a €5 million budget, working in a collaborative environment with the potential for long-term career growth.Responsibilities:Support the...

  • Senior Medical Device Quality Assurance Expert

    2 weeks ago

    Waterford, Waterford, Ireland beBeeAssurance Full time €40,000 - €60,000

    Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to support the design and development of a cutting-edge drug delivery system in a collaborative environment with the potential for long-term career growth.Key Responsibilities:Collaborate with engineers to ensure that all designs meet relevant standards.Participate in...

  • Quality Assurance Specialist

    11 hours ago

    Waterford, Waterford, Ireland beBeeQuality Full time €40,000 - €65,000

    Are you passionate about maintaining top-tier quality standards?We are seeking a Quality Assurance Specialist to join our Foreign Matter Team within the MSAT Laboratory.This hybrid position requires three days on-site, with flexibility for remote work based on team needs and training requirements.Key Responsibilities:

  • Senior Expert, Quality Assurance

    2 weeks ago

    Waterford, Waterford, Ireland beBeeQuality Full time €60,000 - €80,000

    Job Summary:We are seeking a Senior Specialist to provide quality direction and governance across the Quality Management System.This role supports multiple concurrent projects to ensure regulatory compliance throughout the product development lifecycle. Responsibilities include ensuring suppliers deliver products which comply with requirements, leading...

  • Senior Quality Engineer, Design Quality

    2 weeks ago

    Waterford, Waterford, Ireland West Pharmaceutical Services Full time

    Join to apply for theSenior Quality Engineer, Design Qualityrole atWest Pharmaceutical Services2 days ago Be among the first 25 applicantsJoin to apply for theSenior Quality Engineer, Design Qualityrole atWest Pharmaceutical ServicesDescriptionAt West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center...