BD (Tissuemed Ltd)
Business Process Owner, Risk Management
BD (Tissuemed Ltd), San Diego, California, United States, 92189
Overview
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Business Process Owner, Risk Management
role at
BD (Tissuemed Ltd)
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and it takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
This position is a temporary assignment which will include benefits (such as medical, health, dental, 401k). Eligibility for these benefits will be based on eligibility requirements as determined by the BD Total Rewards policy. This position will support remediation activities within MMS and is anticipated to last approximately through October 1, 2026.
Job Description Summary The Risk Management Business Process Owner (BPO), Dispensing is accountable for influencing risk management process activities for product development and product maintenance through the application of quality management and engineering skills for medical devices. This person will support Engineers from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all risk management and other regulatory requirements. This person may also assist with compliance remediation, design control, change control, or wider product development process management projects.
Responsibilities
Owns and ensures Product Risk Management is effectively implemented within the Dispensing and Software Technology Solutions (STS) business units
Works in conjunction with the Risk Management BPO for Infusion and Product Development Process leadership to maintain a comprehensive risk management program across the MMS business unit.
Participates on a team bringing core product development and post-market business processes to the MMS business
Serves as subject matter authority on Product Risk Management
Leads continuous process improvements and partners with SME’s on key initiatives
Ensures consistent application of product risk management activities across all elements of the Quality System (e.g. CAPA, Field Actions, etc)
Establishes training requirements and orchestrates training for Product Risk Management
Monitors performance of Product Risk Management and reports to senior leadership
Benchmark trends in the industry, identify best practices and deploy at BD
Monitors industry surveillance audit outcomes and takes necessary actions to align process to applicable new or revised regulatory requirements and standards
Monitors internal and external audit observations within BD, identifies the appropriate cause and implements fixes across the enterprise for Product Risk Management
Works with standards committee to monitor for external regulatory changes. Determines need for changes to policy, procedure and practices based on regulatory changes and implements where appropriate
Supports regulatory inspections and audits
Participate collaborative community (cross site/cross functional network of SMEs) which will support and drive change
Education And Experience
Requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline. Experience with both hardware and software applications is preferable.
At least 8 years of experience in a Class I/II/III medical device with specific experience in Risk Management
Proven experience with interpretation and application of ISO 14971, FDA CFR 820.30 and other regulation related to Product Risk Management
Demonstrated experience establishing global Quality strategy & oversight, QMS etc., at business/manufacturing site level in a global company.
Strong background in Risk Management in relation to product design and development and post-market risk management activities
Strong understanding of design control requirements and regulation
Proven ability as a change agent to drive improvements across a large organization.
Strong technical writing experience required.
Excellent problem solving and analytical skills.
Ability to develop creative approaches and solutions necessary to resolve complex problems.
Strong communicator capable of interfacing at senior levels.
Understanding of the application of quality systems to the medical device industry.
Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures.
Proven ability to work globally; ability to lead a global team and lead across cultures and regions.
Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions.
Travel is required, given the global scope of the role, and would vary in intensity depending on the evolving business needs.
Compensation and Benefits BD provides a competitive package of compensation and benefits. Salary information is provided in the job posting where applicable. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and location. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$155,900.00 - $257,300.00 USD Annual
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To learn more about BD visit https://bd.com/careers
Equal Opportunity Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
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Business Process Owner, Risk Management
role at
BD (Tissuemed Ltd)
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and it takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
This position is a temporary assignment which will include benefits (such as medical, health, dental, 401k). Eligibility for these benefits will be based on eligibility requirements as determined by the BD Total Rewards policy. This position will support remediation activities within MMS and is anticipated to last approximately through October 1, 2026.
Job Description Summary The Risk Management Business Process Owner (BPO), Dispensing is accountable for influencing risk management process activities for product development and product maintenance through the application of quality management and engineering skills for medical devices. This person will support Engineers from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all risk management and other regulatory requirements. This person may also assist with compliance remediation, design control, change control, or wider product development process management projects.
Responsibilities
Owns and ensures Product Risk Management is effectively implemented within the Dispensing and Software Technology Solutions (STS) business units
Works in conjunction with the Risk Management BPO for Infusion and Product Development Process leadership to maintain a comprehensive risk management program across the MMS business unit.
Participates on a team bringing core product development and post-market business processes to the MMS business
Serves as subject matter authority on Product Risk Management
Leads continuous process improvements and partners with SME’s on key initiatives
Ensures consistent application of product risk management activities across all elements of the Quality System (e.g. CAPA, Field Actions, etc)
Establishes training requirements and orchestrates training for Product Risk Management
Monitors performance of Product Risk Management and reports to senior leadership
Benchmark trends in the industry, identify best practices and deploy at BD
Monitors industry surveillance audit outcomes and takes necessary actions to align process to applicable new or revised regulatory requirements and standards
Monitors internal and external audit observations within BD, identifies the appropriate cause and implements fixes across the enterprise for Product Risk Management
Works with standards committee to monitor for external regulatory changes. Determines need for changes to policy, procedure and practices based on regulatory changes and implements where appropriate
Supports regulatory inspections and audits
Participate collaborative community (cross site/cross functional network of SMEs) which will support and drive change
Education And Experience
Requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline. Experience with both hardware and software applications is preferable.
At least 8 years of experience in a Class I/II/III medical device with specific experience in Risk Management
Proven experience with interpretation and application of ISO 14971, FDA CFR 820.30 and other regulation related to Product Risk Management
Demonstrated experience establishing global Quality strategy & oversight, QMS etc., at business/manufacturing site level in a global company.
Strong background in Risk Management in relation to product design and development and post-market risk management activities
Strong understanding of design control requirements and regulation
Proven ability as a change agent to drive improvements across a large organization.
Strong technical writing experience required.
Excellent problem solving and analytical skills.
Ability to develop creative approaches and solutions necessary to resolve complex problems.
Strong communicator capable of interfacing at senior levels.
Understanding of the application of quality systems to the medical device industry.
Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures.
Proven ability to work globally; ability to lead a global team and lead across cultures and regions.
Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions.
Travel is required, given the global scope of the role, and would vary in intensity depending on the evolving business needs.
Compensation and Benefits BD provides a competitive package of compensation and benefits. Salary information is provided in the job posting where applicable. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and location. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$155,900.00 - $257,300.00 USD Annual
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To learn more about BD visit https://bd.com/careers
Equal Opportunity Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
#J-18808-Ljbffr