BD (Tissuemed Ltd) · 2 days ago
Sr. Design Quality Systems Manager
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$158K/yr - $261K/yr
10+ years expBD is one of the largest global medical technology companies in the world, and they are seeking a Sr. Design Quality Systems Manager to oversee the Quality System Compliance at the San Diego Design Center. The role involves maintaining and improving quality systems, ensuring compliance with design control requirements, and providing strategic direction for quality management initiatives.
Health CareHospitalMedicalMedical Device
Responsibilities
Maintain and improve the IPD San Diego Design Center Quality System, provide strategic direction so that the QS architecture support the business needs and future growth
Establish and maintain QMS linkages with all entities that interact with the IPD San Diego Design Center. Maintains quality agreements
Monitor the effectiveness of the QMS, review key indicators, address negative trends, and prepare Management Review meetings
Maintain effectiveness of the CAPA process
Ensure compliance of the San Diego Design Center QMS, maintain effectiveness of the internal audit program, coordinate external audits and ensure that Design center sites are ready to manage external audits
Ensure effective and consistent application of design controls across all programs in scope of San Diego Design Center; Participate in Design Review meetings and establish and maintain a Design Controls training program
Collaborates with core teams to establish Design Controls and Risk Management implementation strategies in compliance with internal, Industry, and Government Standards
Responsible for Risk Management system. Ensures consistent application of risk management, its effectiveness, and for maintaining compliance with internal, Industry, and Government Standards
Responsible for establishing and maintaining linkages between Risk Management and other processes such as Post Market Quality, Design Control, and Change Control
Provide Quality functional support for labeling programs and labeling process improvement activities
Implement, Measure and Report on the progress of the Quality Management Strategic initiatives, such as Inspire Quality
Software validation
Quality functional support for implementation of electronic systems that that impact the QMS
Leads a team of specialist that support the Quality Management System, including the CAPA and internal audit processes
Assignments are often self-initiated. Determine and pursue course of action necessary to obtain desired results
Participates in, and may provide leadership for multi-disciplinary projects
Considered Site Quality Management System Subject Matter Expert, including Design Controls and Risk Management
Qualification
Required
Bachelor's Degree required in engineering or life sciences related field
Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and planning experience required
Minimum 3 (three) years of direct management experience of QA professional and technical staff
Expertise in regulations affecting medical devices marketed in all regions throughout the world
Expertise in failure investigation and medical device CAPA process
Experience in medical device product development and application of Design Controls
Strong understanding of design quality assurance
Lead Quality System auditor experience
Experience managing regulatory audits and responding to regulatory authorities
Proven leadership capability and teamwork across functions and regions
Ability to manage complex situations and make sound decisions
Preferred
Certified as Engineer or Auditor by the American Society for Quality (ASQ)
Green Belt or Black Belt from a recognized program
Experience working in a design center
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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