Director Quality Management

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Job description

Summary: The Quality Management Director is responsible for global regulatory affairs and quality assurance activities. The Quality Management Director is also responsible for advising and consulting with stakeholders about compliance with applicable FDA regulations, Health Canada regulations, and other applicable standards. The QM Director will research, recommend, and implement best practices, and contribute to both the strategic and operational functions of the regulatory affairs and quality assurance teams. Plans, coordinates, and directs the quality and regulatory assurance program designed to ensure quality production of products consistent with established standards by performing the following duties personally or through subordinate supervisors.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Formulates and maintains quality assurance objectives complementary to corporate policies and goals.
• Interprets quality assurance philosophy to key personnel in the organization.
• Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Decides whether to accept a product or continue business with a vendor based on a review by the quality assurance engineer.
• Reviews all data obtained during all quality assurance activities to ensure consistency with company policies and procedures.
• Works with cross-functional teams to develop new approaches to solve problems identified during quality assurance activities.
• Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
• Keeps management team abreast of significant changes or developments around regulatory assurance.
• Facilitates Management Review.
• Prepares and presents technical and program information to the management team.
• Directs technical and administrative workers engaged in regulatory affairs and quality assurance activities.
• Maintains a working knowledge of government and industry regulatory affairs and quality assurance codes and standards.
• Plays an active role leading and directing the quality management teams within the organization.
• Designs and implements quality assurance training programs to key personnel in conjunction with managers.
• Investigates and adjusts customer complaints regarding quality.
• Facilitates all internal and external audit activities.
• Promotes a culture of Compliance that includes GMP (Good Manufacturing Practices).
• Manages compliance with ISO 13485 and 21CFR820.
• Manges KPI (Key Performances Indicators) and daily management for the quality department.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

• Extensive knowledge of ISO 13485 and 21CFR820.
• Knowledge of regulatory and governing bodies outside the United States.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem-solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
• Cost Consciousness - Works within approved budget; Develops and implements cost-saving measures; Contributes to profits and revenue; Conserves organizational resources.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethics; Upholds organizational values.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.