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 of 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.

Job Description

Key Responsibilities

Manages the various quality programs for the EMI Hub. These include CAPA, NCR, Internal Audits, Quality Certificates, Training, Calibration, Customer Quality Agreements, Customer Complaints, Analysis of Data, Design & Development, etc. Collaborates with cross functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues. Actively participated in external regulatory inspections and audits. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management. Assists with FDA and external audit readiness at BD sites. Ensures the CAPA Program is established and maintained. Ensures that the training program is effectively implemented, and that appropriate training is assigned, provided and monitored to ensure Business training compliance goals are met. Establish and maintain processes to analyze Quality Data from the EMI Sites. Assist with the preparation for EMI Management Review. Provide guidance and training to the Device sites in various quality system areas such as CAPA, Internal audits, Analysis of Quality Data, Complaint Management, etc. Supports company initiatives aimed at improving and standardizing the Quality Systems processes. Represents EMI in Quality Networks (such as CAPA, Training, Quality Notification, Customer Complaints etc.). Collaborates with the Unit/Site Quality EMI Leaders to seek their input and support in implementing the Network objectives at the EMI sites. Establishes and Implements worldwide policies and procedures aimed at harmonizing the Quality Systems at EMI Sites worldwide. Manages and coordinates the Quality Systems staff. Carries out Human Resource management responsibilities such as hires, job assignments, coaching, termination recommendations, promotions, salary actions, and processes performance reviews on time. Responsible for planning, developing, and executing CI blitzes in conjunction with other functions and the sites. Develop and maintain an influential and effective network and communication with peers and leadership team members for identifying improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies. Establishes measuring and tracking mechanisms that record measurable results of CI in terms of process efficiency, customer satisfaction, financial and non-financial benefits, and transfers those mechanisms to the functions.  Benchmarks internal and external organizations. Develops and maintains an overall dashboard to track CI program/project progress and develops other communication mechanisms. Benchmarks internal and external organizations. Identifies, implements, leverages, teaches, and transfers best practice knowledge to and through the organization. Assists functions in utilization of best practices (Manufacturing Six Sigma, Design for SS, Lean, CI Tools). Identifies, implements, leverages, and transfers best practice knowledge to the EMI organization. Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions. Continuously evaluate progress toward objectives adapting them to meet customer and business needs. Other assignments as directed by the Vice President Quality Management EMI .

Education

Bachelor’s degree in a technical field required. Engineering degree strongly preferred.  Master’s degree in a technical field preferred.

Experiences

Minimum of ten (5) years’ experience in the following areas: Electromechanical Instrumention, 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 European/US 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.

Required Skills

Optional Skills

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Primary Work Location

MEX Tijuana - Parque Sur

Additional Locations

Work Shift