Job Description SummaryThe Associate Director, Quality Media serves as Plant Quality leader for the BD IDS Media plants and has responsibility for applying/interpreting the applicable Quality Systems and developing/implementing the Standard Operating Procedures for that site. Through outstanding communication, effective problem solving and active management of ambiguous situations the Associate Director ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. Provides interpretation of companywide policies and procedures and ensures their appropriate implementation.
Develops and maintains budgets, schedules and performance requirements. Mentor and develop personal including identification and development of high potential associates within the quality organization.
Responsibilities include understanding the key drivers in the organization to set and execute operational objectives with the leadership team. Develops strategies that support the business and the Quality organization.
Also responsible for assuring departmental compliance with ISO and FDA requirements through supporting supplier audit program, delegating participation on product enhancement teams, supporting a robust CAPA program, and ensuring that all aspects of the Quality Management System have the appropriate Quality oversight and maintenance to ensure a continuous state of compliance.
Job Description DUTIES AND RESPONSIBILITIES:
MINIMUM QUALIFICATIONS:KNOWLEDGE AND SKILLS:
- Functions as the Management Representative for the Media plant quality management system
- Responsible for the Quality Engineering, Quality Control, and Finished product release department including the evaluation of Quality Control results and the decision to release products. Ensures that the quality system is established and maintained efficiently, reports the quality system performance to management for review and promotes awareness of regulatory and customer requirements throughout the organization;
- Responsible for developing, managing, maintaining, reporting, and improving plant quality metrics which includes Plant/Site Management Review for IDS Instruments. Evaluate metrics to determine if quality problems exist and set the appropriate action and escalation
- Decisions have an extended impact on work processes and outcomes. Erroneous decisions result in critical delays and modification to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business performance
- Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
- Implements strategic policies when selecting methods and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans and performance requirements. This position is accountable for responsibilities with high complexity. Has in-depth understanding of quality and regulatory principles.
- Establishes operating policies and procedures that affect business unit as well as local departments.
- Contributes to the development of strategies.
- Interprets company-wide policies and procedures. Develops budgets, schedules and performance standards.
- Regularly interacts with senior management or executive levels on matters concerning cross-functional areas and/or external customers.
- Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
- Often serves on Leadership Teams such as Business Line (BL), Plant LT (Leadership Team), Extended Quality LT at the JG5+ level (EQLT)
- Establishes operational objectives and work plans; delegates assignments to associates.
- Manages subordinate managers and/or experienced specialist employees who exercise significant latitude and independence
- Advances the Leadership Bench strength of the company.
- Manages quality assurance activities for development (compliance with procedures, risk analysis, quality plan) and the manufacturing of BD IDS products (quarantine and release, calibration, certificate of analysis, reports of non-compliance analysis, trend analysis);
- Supports the implementation of activities including solving problems associated with these activities;
- Collaborates with other BD Quality Leaders and participants on projects with participants from other BD plants.
MINIMUM EDUCATION AND EXPERIENCE:
- Experience in managing people
- Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) and ISO 13485:2016
- Knowledge of laws, regulations, standards and guidelines governing the sale of medical devices in Canada, the United States and Europe.
- Ability and skill to effectively manage multiple tasks and drive execution of organizational objectives and strategies
- Ability and skill to lead a management team in managing subordinates and executing organizational objectives and/or strategies
- Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
- Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and senior management/executive level
- Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
- Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
- Ability to identify and develop medium and high potential associates
- Ability to manage budgets, work schedules and performance requirements
- Bachelor of Science (BSc) or Engineering (B.Eng.) REQUIRED, and 8 years experience in Quality, Regulatory, or Operations of a Medical Device firm in a supervisory role.
- Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Etc)
- Black Belt in Manufacturing or Transactional Six Sigma, DFSS or equivalent in ASQ Certification (CQE) & Experience, preferred
Primary Work LocationUSA MD - Baltimore 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.
Posting ID: 558409251Posted: 2020-05-22