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We Make Life More Rewarding and Dignified
Location: Ballina
Department: Quality
Senior Quality Compliance Engineer – 24-month contract
Job Summary:
We are seeking a proactive and detail-oriented Quality Compliance Engineer to join our Quality Assurance team. This role is essential in ensuring compliance with regulatory standards and continuous improvement of product quality through the investigation of customer complaints, implementation of corrective and preventive actions (CAPAs), and cross-functional collaboration. The successful candidate will play a key role in maintaining product integrity, analyzing data trends, and supporting regulatory submissions through technical documentation.
Key Responsibilities:
* Conduct thorough investigations into Customer Complaints, identifying root causes and ensuring timely resolution in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
* Develop, implement, and monitor Corrective and Preventive Actions (CAPAs) to mitigate identified risks and prevent recurrence of quality issues.
* Perform data collection and analysis related to product performance, complaints, non-conformances, and process deviations; present findings in a clear and actionable manner.
* Author and maintain high-quality technical documentation, including investigation reports, CAPA records, risk assessments, and trend analyses.
* Collaborate closely with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, and Customer Service) to drive resolution of quality issues and ensure compliance with internal and external standards.
* Support internal and external audits by preparing documentation, participating in audit activities, and following up on audit findings.
* Participate in continuous improvement initiatives and projects to enhance quality systems, processes, and product reliability.
* Ensure timely completion of quality records in electronic quality management systems (eQMS).
Qualifications:
Required:
* Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or Life Sciences.
* 5-8years quality assurance or compliance in the medical device or a similarly regulated industry or 3 years experience in a similar role with a relevant level nine qualification
* Solid understanding of FDA QSR, ISO 13485, ISO 14971, and relevant international regulations.
* Strong analytical and problem-solving skills; experience with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).
* Excellent written and verbal communication skills, especially in technical writing and documentation.
* Proficient in data analysis tools such as Excel, Minitab, Power BI or similar.
Preferred:
* Experience with post-market surveillance and complaint handling processes.
* Six Sigma or Lean Certification is a plus.
* Knowledge of EU MDR and international medical device regulations.
* Strong attention to detail and commitment to quality.
* Ability to manage multiple tasks and projects in a fast-paced environment.
* Collaborative mindset with ability to work effectively across departments.
* Self-motivated with a continuous improvement mindset.
EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job Segment: Compliance, Regulatory Affairs, Quality Assurance, Technical Writer, Legal, Technology, Customer Service
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