Job Title: Manager of Quality Assurance
Responsible and accountable for aggressive continuous improvement initiatives geared towards transformation of the Quality Management System in order to: 1) assure strict regulatory compliance of all applicable systems and elements, and 2) enable lean transformation of plant operations in accordance with the Operational goals. Responsible for managing and directing the daily aspects of the manufacturing quality, documentation, calibration, and laboratory systems, as applicable, at the CareFusion Palm Springs facility located in Palm Springs, CA. Also responsible for managing the processes addressing employee training, internal assessments, supplier quality, ISO 13485:2003, 21 CFR Part 820 Quality System Regulations, Medical Device Directive, Canadian Medical Device Regulations, JPAL, and other regulatory compliance to corporate, federal, and international standards. Prepares and manages departmental operating budget. Directs and develops departmental and plant personnel.
Responsible for ensuring the facility produces quality products as per customer requirements and complies with all applicable federal (21 CFR Part 820) and state regulations and international standards (ISO 13485:2003, MDD, CMDR, J-Pal, and ISO 14971).
• Implements and maintains a Quality departmental structure that is aligned to the facility value stream.
• Ensures that quality objectives are continuously achieved.
• Manages quality personnel within the facility to include raw material inspection, quality technicians, calibration, documentation, and quality engineering.
• Keeps Plant Operations Director and Quality Director informed on all key issues
• Tracks, trends, and reports all key quality indicators
• Responsible for ensuring the suitability and effectiveness of the risk management process as per ISO 14971.
• Implements quality systems which comply with CareFusion Policies, CFR Title 21 Part 820, ISO 13485:2003, Health Canada Medical Devices Regulation and Medical Device Directive 93/42/EEC.
• Based on key imperatives and the management agenda established by the business unit management, provide direction and leadership to the business unit management regarding significant product and service quality decisions. Provides quality trend information to aid in achieving these objectives
• Provides direction and leadership including change management to quality personal in order to maintain and improve quality operations within the plants.
• Interact with external compliance authorities to demonstrate regulatory compliance and product safety and efficacy.
• Recruit, retain, train, develop, manage and lead quality personnel.
• Provides active support and implementation of lean six sigma tools and methodologies to improve plant compliance, product quality, and cycle time in quality performance.
• Initiate and direct corrective actions related to product or process quality.
Job Family Summary
QRA Management is responsible for tactical and strategic leadership within the QRA function.
What is expected of you and others at this level in Quality & Regulatory Affairs for functional success
· Manages professional employees and/or supervisors; may manage business support, technical or production staff
· Has accountability for managing financial resources
· Provides technical guidance to employees
· Develops processes and procedures to implement functional strategies
· Has in-depth expertise in own job family and knowledge of the related job families
· Applies expertise to improve effectiveness and provide guidance to employees in own area
· Makes decisions, often difficult and/or unpopular, that impact the work of subordinates within job family; influences subordinates to support decision by presenting rationale/business case
· Role models CareFusion's high ethical standards and code of conduct
· Recognizes development needs and capability gaps in own area and arranges specific projects/assignments to address needs
· Proactively identifies talent internally and externally, including participation in succession planning process for job family
· Cascades organizational goals through the function/work area to the individual level and ensures individuals understand how they can contribute
· Builds confidence and respect of others through a positive and energizing style
· Accepts responsibility for establishing goals and achieving results within own job family, holding self and others accountable for results
· Manages budget for own area and allocates resources accordingly, applying knowledge of profit drivers within own area/job family
· Interprets internal/external business issues and adapts work priorities in own area
· Assists in the definition of strategic plans for own work team/job family or key product(s)/service(s)
· Works with customers to anticipate and interpret customer needs and business challenges
· Identifies quality and service-oriented customer solutions and shares key learnings with others
· Resolves operational problems that impact the effectiveness of own area
· Encourages subordinates to strive for operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to maximize results; serves as a role model in innovative thinking and in focusing on quality within work
· Works collaboratively with internal/external groups to achieve business results, integrating the diverse perspectives of individuals of different backgrounds; coaches others in the dynamics of effective teamwork
Effectively solicits and explains difficult concepts and persuades others to adopt a point of view; states own point of view
• BS in Science, Technology, Engineering or equivalent. Advanced degree preferred.
• 5 - 7 years experience in the quality department of a medical manufacturing-based organization.
• 3 - 5 years people management experience
• Strong, comprehensive knowledge of ISO 13485:2003, 21 CFR Part 820 Quality System Regulations, Medical Device Directive, Canadian Medical Device Regulations, JPAL, and ISO 14971.
• Must be able to make decisions quickly and concisely and be able to execute decisions appropriately.
• Must have strong organizational and interpersonal skills.
• Application of Lean Six Sigma to manufacturing processes required
• LSS Black Belt Certification is highly desired
• ASQ Certification as CQE, CSSBB, or CQA strongly preferred.