Associate Director – Plasma & Vaccine Device Quality
Takeda
full-time
Posted on:
Location Type: Office
Location: Lexington • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $153,600 - $241,340 per year
Job Level
Senior
About the role
- Provide quality leadership for medical device and combination product life cycle management
- Drive collaboration with internal and external partners on life cycle management efforts
- Ensure compliance with global regulatory requirements and international standards
- Identify, lead, and implement Continuous Improvement (CI) projects
- Accountable for Device Quality functions in oversight of drug delivery devices
- Conduct risk management and post-market surveillance activities
- Manage customer feedback and complaint investigations
- Mentor others in supplier qualification processes
- Lead internal and external audits as a device quality SME
Requirements
- BS and/or MS in engineering or equivalent technical discipline required
- 7+ years of device life cycle management / quality assurance
- Minimum of 4 years in device quality
- Extensive knowledge of US and International Device regulatory requirements (21 CFR Part 820, ISO 13485, ISO 14971)
- Strong analytical skills
- Strong project management capabilities
- Experience in leading design quality activities and influencing senior management
- Experience with statistical and DMAIC methods
- Experience with risk management processes and tools
- Experience with Class I, Class II, or III medical devices
- Experience interacting and collaborating with cross-functional global teams
Benefits
- Medical, dental, vision insurance
- 401(k) plan and company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Up to 80 hours of sick time per calendar year
- Accrue up to 120 hours of paid vacation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
device life cycle managementquality assurancerisk managementstatistical methodsDMAIC methodspost-market surveillancesupplier qualificationdesign quality activitiesregulatory complianceauditing
Soft skills
leadershipcollaborationanalytical skillsproject managementmentoringcommunicationinfluencingcustomer feedback managementproblem-solvingteamwork