Bd (becton, dickinson and company) sr. Manager, emi quality systems and customer quality in tijuana, mexico
job description summary
the sr. Manager quality systems and customer quality emi (electromechanical instrumentation) reports to the vice president of quality emi. This role is responsible for developing and maintaining quality assurance programs, policies and procedures for emi. It will work across bus and central quality to align process and procedures for the emi site. This role will also focus on driving manufacturing quality issues to completion and developing dashboards for reporting out on overall emi quality performance.
the sr. Manager quality systems and customer quality will be responsible for ensuring the appropriate quality agreements are in place as the emi strategy is implemented. It will also be responsible for oversight of quality bd excellence initiative across the emi sites and will be responsible for implementation of dashboards to track metrics and performance of the emi sites. Quality system team members report directly to the sr. Manager and are under their authority for performance reviews, career development, compensation, hiring, and termination. The sr. Manager also partners with manufacturing, supply chain and procurement leaders, operating with independence to strengthen and improve emi management and governance.
the role will have responsibility for providing leadership and support for continuous improvement programs through use of six sigma (manufacturing, transactional and design for six sigma), lean, validation, ci tools and project management best practices.
key responsibilities
1. manages the various quality programs for the emi hub, including capa, ncr, internal audits, quality certificates, training, calibration, customer quality agreements, customer complaints, and analysis of data.
2. collaborates with cross-functional partners such as quality engineering, r&d, operations, medical, and marketing to develop policies and procedures and address quality issues.
3. participates in external regulatory inspections and audits, ensuring pre and post-inspection activities are completed.
4. prepares responses to audit nonconformities for review by senior management.
5. assists with fda and external audit readiness at bd sites.
6. ensures the capa program is established and maintained.
7. implements an effective training program to ensure business training compliance goals are met.
8. establishes processes to analyze quality data from the emi sites.
9. provides guidance and training to device sites in various quality system areas.
10. supports company initiatives aimed at improving and standardizing the quality systems processes.
11. represents emi in quality networks and collaborates with unit/site quality emi leaders.
12. establishes and implements worldwide policies and procedures for harmonizing quality systems at emi sites.
13. manages and coordinates the quality systems staff and carries out human resource management responsibilities.
14. plans, develops, and executes ci blitzes in conjunction with other functions and the sites.
15. develops and maintains an influential network with peers and leadership to identify improvement opportunities.
16. establishes measuring and tracking mechanisms for ci results.
17. benchmarks internal and external organizations.
18. identifies and implements best practice knowledge within the organization.
19. effectively navigates and leads through the challenges of change.
20. continuously evaluates progress toward objectives adapting them to meet customer and business needs.
education
bachelor’s degree in a technical field required. Engineering degree strongly preferred. Master’s degree in a technical field preferred.
experiences
minimum of five (5) years’ experience in electromechanical instrumentation, quality assurance/control, statistical analysis, fda qsr’s (21 cfr part 820), lean manufacturing, risk management (iso 14971), and iso/ec (mdd/mdr, ivdd/ivdr, mdsap, cmdr, iso 13485, j-pal) requirements.
required knowledge and skills
* knowledge and application of iso 13485, 21 cfr 820 and 21 cfr 210-211, mdd/mdr, ivdd/ivdr requirements and gmps related to medical device and pharmaceutical manufacture.
* experienced in project management.
* experience in continuous improvement/lean manufacturing principles.
* organisational / motivational skills.
* capable of managing a range of projects and activities in parallel.
* the ability to manage by influence in addition to functional responsibility.
* the preparation, planning and presentation of key initiatives.
* the ability to coordinate effectively across regions.
primary work location
additional locations
work shift
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.
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