品質管理条件を変える閉じる
要約求人票をもとにAIがまとめたものです
The Quality Systems Lead will maintain and enhance the Ireland Design Center's Quality Management System and drive compliance and continuous improvement. The role supports medical device and IVD product development, risk management, audit readiness, and regulatory compliance while partnering with U.S.-based Legal Manufacturer teams.
応募資格
歓迎
- Bachelor's degree in Engineering, Life Sciences, or another technical discipline.
- At least 8 years of experience in a regulated industry such as medical devices, diagnostics, pharmaceuticals, or biologics.
- Strong knowledge of FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR, and product development quality requirements.
- Proven experience supporting Design Controls, CAPA, change control, audit management, risk management, and regulatory inspections.
- Ability to influence, build effective working relationships, and make sound decisions in complex environments.
- Experience using electronic quality management systems such as TrackWise, Veeva, Agile PLM, SAP, or Windchill, combined with strong communication, problem-solving, and project management skills.
募集要項最終確認 9/25
- 職種
- 品質管理
- 雇用形態
- 記載なし
- 役職
- Quality Systems Lead
- 給与
- 記載なし
- 給与の詳細
- Salary range for the role:** €85.000 to €90.000 per annum
- 勤務地
- IRL Limerick - Castletroy
- 働き方
- In-Office, Limerick, Munster
- 福利厚生
- At BD, we reward, support and develop our associates through our comprehensive Total Rewards program.We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
- 学歴
- 大学卒業以上
- 掲載日
- 2026/09/25 21:04（4日前）
- 最終確認
- 2026/09/25 21:04（4日前）
仕事内容
Job Description
Join our Ireland Design Center as a Quality Systems Lead, where you will play a key role in supporting medical device and IVD product development activities while partnering with U.S.-based Legal Manufacturer teams.
As the site's Quality Management System (QMS) expert, you will drive compliance, continuous improvement, and quality excellence across development and operational processes.
In this individual contributor role, you will maintain and enhance the site's QMS, ensuring alignment with global quality standards and regulatory requirements.
You will work closely with cross-functional teams to support product development, risk management, audit readiness, and ongoing compliance initiatives that contribute to the delivery of safe and effective healthcare solutions.
Responsibilities
Lead the implementation, maintenance, and continuous improvement of the site's Quality Management System.
Ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR, and other applicable regulatory requirements.
Act as the primary quality partner for Engineering, Regulatory Affairs, Research & Development, and facility management teams.
Support Design Verification, Design Validation, and Risk Management activities throughout the product development lifecycle.
Manage key quality processes, including document control, training, change control, CAPA, audit management, and compliance assessments.
Coordinate and support external audits, inspections, and regulatory reviews.
Monitor QMS effectiveness through quality metrics, management reviews, and performance assessments.
Deliver quality training and promote a culture of compliance, continuous improvement, and accountability.
この求人は日本ベクトン・ディッキンソン株式会社の採用ページの掲載内容をもとに構成しています。応募条件の最新情報は募集元をご確認ください。
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応募は日本ベクトン・ディッキンソン株式会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。