LifeScience Segment Post Market Quality Ops - Manager
Job Description SummaryAs LifeScience Segment Post Market Quality Ops - Manager, you will report to the Director, Post Market Quality Operations, and provide direct management to technical and supervisory staff. The role contributes to strategy and determines tactics required to achieve plant, business unit and functional objectives. Through outstanding communication and effective problem solving, the manager ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. The Manager produces durable and industry leading results by supporting key business drivers in both USA and the Canada Region.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Our vision for Quality at BD
Our Inspire Quality strategy is to become a best-in-class quality organization. Quality is at the core of what we do to provide safe, effective products and services to patients; it is the foundation of patient and customer trust as we continue advancing the world of health.
Key responsibilities will include:
- Ensure Complaints Management end to end process is in compliance with all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality and Regulatory Compliance Policies. (i.e. product complaint intake, Global (FDA) MDR reporting, customer communications)
- Execute E2E complaint management processes across all business units to improve customer experience and reduce escalated issues.
- Provide leadership directives; mentor and develop associates.
- Build strong, influential and effective relationships with business, regions, and functional and technical partners to build trust and influence multiple levels within the organization.
- Ensure complaints management and customer relations group is aligned with “Go to Market” strategy, enhancing the customer experience and ensuring customer excellence.
- Employ best practices, and apply continuous improvement and IT tools to accelerate Quality excellence.
- Influence and/or lead initiatives to drive process complaints management optimization, and support the adoption of process initiatives to reinforce the need for change.
- Proactively engage organizational leadership and communicate project progress, issues and solutions.
- Lead internal audits, corporate audits and notified bodies audits.
Primary Responsibilities and Duties
- 25% Engage with quality networks as well as business unit and associates by effectively promoting and aligning organizational goals with the company’s mission and vision. Pursue and actively manage key stakeholder relationships.
- 20% Ensure function is organized and resourced to fulfill obligations and align with applicable regulations and procedures.
- 10% Mentor and develop personnel, including dedicated succession planning and contingency management.
- 10% Continuously evaluate progress toward objectives adapting them to meet customer and business needs.
- 5% Pursue and maintain a functional knowledge of global regulations.
- 10% Manage customer impacting issues; prioritize solutions that uphold company standards.
- 10% May serve as “management representative” for notified bodies and liaison with regulatory authorities and customers by hosting and managing related audits and ensuring effective resolution.
- 10% As appropriate, serves on Leadership Teams such as ESC (Executive Steering Committee), Plant LT (Leadership Team), Extended Quality LT.
- Moderate Travel (15%) to Salt Lake City and/or San Antonio site.
To be successful in this role, you require:
- High level problem identification, and analysis skills, and the ability to formulate technical and business solutions.
- Strong product knowledge.
- Motivation, self-direction, and the ability to prioritize and work with minimal supervision.
- Teamwork, influence and collaboration skills as well as mentoring and people development skills.
- The ability to develop and maintain a diverse workforce and work environment.
- Experience in complaints management, recalls and customer escalated issues.
- Strong analytical, deductive reasoning and listening skills.
- Ability to influence without authority and deal effectively with ambiguity.
- Strong customer service and skills.
- Strong project management skills.
- Demonstrated use of computer based analytical, statistical and modeling tools to identify and improve processes; must be proficient in excel, and able to quickly demonstrate proficiency in complaint handling platforms.
Education and experience required:
- BA or BS degree or 6 years’ relative experience in lieu of a degree.
- A minimum of 8 years relevant experience or a combination of equivalent education and 10 years proven experience.
- CAPA investigations experience and extensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485/ISO 14971.
- Stong demonstrated experience in data management and the preparation of materials for meetings and presentations.
- Advanced knowledge in Excel and Access.
- Demonstrated abilities in building a tailored complaints communication model and in developing a Customer Escalation Process and Dashboard.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
Primary Work LocationUSA UT - Sandy
Additional LocationsUSA TX - San Antonio
Recommanderà un ami
Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ