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Quality System Specialist jobs in United States
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BD · 23 hours ago

Quality System Specialist

BD is one of the largest global medical technology companies in the world, committed to advancing the world of health. The Quality System Specialist will be responsible for ensuring system reliability and regulatory compliance while optimizing digital solutions supporting the organization’s Quality Management Systems.
Medical DeviceHealthcareHealth CareTechnical Support
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Support end users with process and system usage related questions; this includes partnering with TGS (Technology & Global Services) on issue resolutions and communication with end users
Provide on-demand user support and troubleshoot data/system issues
Collaborate with Global Process Owners (GPO) to collect, interpret, and analyze business requirements to shape the design of the quality management system
Identify opportunities for system improvements and lead initiatives to enhance system efficiency, user experience, and overall quality management capabilities
Shape project direction and timeline and make recommendations that include alternative solutions
Support validation and testing activities; this includes authoring PQ test scripts and support execution in alignment with validation protocols
Ensure the system is compliant with applicable regulatory agency requirements and company policies
Work closely with cross-functional teams to ensure the system meets business needs and compliance requirements
Develop and deliver training programs to ensure employees are knowledgeable about quality systems, procedures, and best practices
Support dashboard metrics development, ad hoc data extraction, and data analysis

Qualification

Quality Management SystemsRegulatory ComplianceData AnalysisQuality Management SoftwareProject ManagementAnalytical SkillsTraining DevelopmentPegaTrackWisePower BIAIChange ControlComplaint ManagementCAPAAudit ProgramsProblem-Solving SkillsCommunication SkillsTeam PlayerSelf-MotivatedPresentation SkillsAttention to DetailAdaptability

Required

Bachelor's degree, preferably in Quality Management, Engineering, Life Science or Technology field
Minimum of 3 years of experience in quality management systems within a regulated industry (e.g., medical devices, pharmaceuticals)
Excellent analytical, problem-solving, and project management skills
Strong attention to detail and ability to manage multiple priorities
Exceptional written and verbal communication skills with the ability to lead and influence cross-functional teams
Proficient in quality management software and tools, as well as Microsoft Office Suite
Effective meeting and presentation skills
Candidate must be self-motivated, self-directed, a team player, and willing to learn & adapt

Preferred

Preferred experience working with Pega, TrackWise, Power BI, AI, Product Holds, Change Control, Complaint Management, CAPA, Field Actions, Audit Programs

Benefits

Annual Bonus
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Paid time off (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave

Company

BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.

H1B Sponsorship

BD has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)

Funding

Current Stage
Public Company
Total Funding
$540M
Key Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO

Leadership Team

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Tom Polen
Chairman, CEO and President
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Richard Byrd
Executive Vice President and President Interventional Segment
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Company data provided by crunchbase