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Quality Engineer II

  • On-site
    • Galway, Connaught, Ireland
  • Quality Assurance

Job description

Our Client, a very exciting Medical Device startup, are searching for a Quality Engineer II to join their growing team.

Please note: This role is fully onsite with no hybrid or remote working options.

Responsibilities include but are not limited to the following:

  • Responsible for compliance with Companies Policies and Procedures and applicable National and International Regulations.

  • Leads compliance and improvement activities associated with the companies quality system (e.g. CAPA, audit programs, personnel training).

  • Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

  • Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.

  • Provide expertise in the areas of quality assurance, controls and systems to support and develop the Companies QMS.

  • Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.

  • Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics.

  • Provide ongoing support to the internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercial.

  • Gather and analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations and internal requirements

  • Prepare and maintain detailed records of inspections, testing, and non-conformance reports.

  • Collect, analyze, and report key data related to product testing, supplier performance, and internal quality metrics.

  • Use data-driven insights to drive continuous improvement initiatives, ensuring optimal product quality and process efficiency.

  • Develop test protocols or reports to support the design validations and verification activities.

  • Support the quality control activities, relating to lot release of finished devices, received products or other QC activities.

  • Review and approval of changes to product, processes for existing medical device products are conducted in compliance with global regulations and internal procedures.

Job requirements

  • A degree in quality engineering, life science or related field.

  • 3-5 years experience at a quality assurance role in the medical device sector essential, preferably in a FDA/MDR regulated environment.

  • Quality certification and lead Auditor certification an advantage.

  • Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016

  • In-depth knowledge of quality engineering principles, methodologies, and tools (e.g., FMEA, SPC, Root Cause Analysis, CAPA, investigations etc.).

  • Experience in the QA activities associated with the design and development of medical devices.

  • Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.

  • Excellent interpersonal skills and ability to work with people to achieve results.

  • Excellent written and communication skills, fluency in English, attention to detail and strong technical writing skills.

  • Proven record of policy and procedure development.

  • Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making.

  • Highly motivated with excellent communication skills and proven ability to work effectively as part of a team an interact professionally with all organizational levels.

  • Proficiency in MS office products.

  • Good business acumen and an enthusiastic self-starter.

Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies

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