BlueWind Medical
Get AI-powered advice on this job and more exclusive features.
Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity Direct message the job poster from BlueWind Medical Supporting Design Control / PDP Process as Quality Lead Approval of qualification and validation activities Quality Lead on Risk Management activities Prepare, implement and maintain quality procedures to ensure QMS in compliance with FDA-QSR, AIMD/MDR & ISO13485 Applying risk-based approach in QMS processes Training and qualifying the company employees Document Control management and retention CAPA process handling Support external audits Assess the quality procedure effectiveness by planning and conducting Internal Quality Audits Prepare inputs for management review including quality data analysis / trends Maintaining the quality system Create and realize quality plans Education/Qualification Requirements Bachelor's degree in life science-related discipline or engineering Experience Requirements At least 7 years of experience in similar positions, preferably in the medical device industry including ISO 13485, FDA QSR and EU AIMDD /MDR Previous experience in external and internal audits, certified as an internal auditor and lead auditor 5 years QMS experience including: Design Control, Risk Management, CAPA, Document Control, Training, KPIs, Customer complaints Capable of self-learning of applicable medical background Seniority level
Seniority levelNot Applicable Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesMedical Device Referrals increase your chances of interviewing at BlueWind Medical by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Tuition assistance Get notified about new Quality Assurance Specialist jobs in
Boston, MA . Boston, MA $75,000.00-$95,000.00 3 months ago Manager, Quality Assurance (QA), Global QMS Canton, MA $70,000.00-$90,000.00 3 days ago Associate Director/ Director, Quality Assurance Boston, MA $71,453.20-$102,351.00 1 month ago QA Specialist II, Validation, Contractor Canton, MA $70,000.00-$85,000.00 16 hours ago Lowell, MA $105,000.00-$125,000.00 3 weeks ago Quality Assurance Specialist/Manager – Bioanalytical LaboratoryQuality Assurance and Facilities ManagerAssociate Manager, Quality Assurance (Accessories)Quality Control Specialist- Gas Operations Somerville, MA $92,820.00-$103,130.00 6 days ago Quality Assurance Engineer-CMM exp required - Manufacturing Co. Beverly, MA $80,000.00-$110,000.00 2 hours ago Senior Manager, Global Pharmacovigilance (PV) Quality AssuranceQuality Control Specialist- Gas Operations We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity Direct message the job poster from BlueWind Medical Supporting Design Control / PDP Process as Quality Lead Approval of qualification and validation activities Quality Lead on Risk Management activities Prepare, implement and maintain quality procedures to ensure QMS in compliance with FDA-QSR, AIMD/MDR & ISO13485 Applying risk-based approach in QMS processes Training and qualifying the company employees Document Control management and retention CAPA process handling Support external audits Assess the quality procedure effectiveness by planning and conducting Internal Quality Audits Prepare inputs for management review including quality data analysis / trends Maintaining the quality system Create and realize quality plans Education/Qualification Requirements Bachelor's degree in life science-related discipline or engineering Experience Requirements At least 7 years of experience in similar positions, preferably in the medical device industry including ISO 13485, FDA QSR and EU AIMDD /MDR Previous experience in external and internal audits, certified as an internal auditor and lead auditor 5 years QMS experience including: Design Control, Risk Management, CAPA, Document Control, Training, KPIs, Customer complaints Capable of self-learning of applicable medical background Seniority level
Seniority levelNot Applicable Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesMedical Device Referrals increase your chances of interviewing at BlueWind Medical by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Tuition assistance Get notified about new Quality Assurance Specialist jobs in
Boston, MA . Boston, MA $75,000.00-$95,000.00 3 months ago Manager, Quality Assurance (QA), Global QMS Canton, MA $70,000.00-$90,000.00 3 days ago Associate Director/ Director, Quality Assurance Boston, MA $71,453.20-$102,351.00 1 month ago QA Specialist II, Validation, Contractor Canton, MA $70,000.00-$85,000.00 16 hours ago Lowell, MA $105,000.00-$125,000.00 3 weeks ago Quality Assurance Specialist/Manager – Bioanalytical LaboratoryQuality Assurance and Facilities ManagerAssociate Manager, Quality Assurance (Accessories)Quality Control Specialist- Gas Operations Somerville, MA $92,820.00-$103,130.00 6 days ago Quality Assurance Engineer-CMM exp required - Manufacturing Co. Beverly, MA $80,000.00-$110,000.00 2 hours ago Senior Manager, Global Pharmacovigilance (PV) Quality AssuranceQuality Control Specialist- Gas Operations We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr