Quality Supervisor

· Review project plans for achievability and alignment with strategy, approve goals, and monitor milestone achievement.

· Manage area consistent with business goals.

· Participate in the development of procedures to implement strategy.

· Ensure communications flow is not interrupted.

· Ensure that practices, activities and projects support the quality or regulatory strategy, contribute to the development of QA or RA and business strategies.

· Provide advice and counsel to resolve issues where precedents exist,recognize and remove barriers to project or task completion.

· Define resource requirements, assign resources to tasks, manage assigned team.

· Prepare input to the development of processes to meet goals, work on process improvement, direct and plan process implementation.

· Participate in the translation of customer needs into products and process requirements, identify issues affecting customer satisfaction and recommend programs to address those issues and prevent defects.

· Manage human resources, i.e., set performance goals, monitor and review performance, write and conduct appraisals for employees, recommend staffing levels, provide input to succession planning, provide input to salary budget, deliver rewards and sanctions.

· Responsible for implementing and maintaining the effectiveness of the quality system. Serve as role model for staff, coach staff and team members to enhance professional development.

· Complete performance reviews and assist with development planning for individuals within the group.

· Assure that unit goals and objectives are communicated.

· Develop personnel, identify backups for their positions, may propose succession plans for management review.

· Reviews goals of staff,prepares own goals for review.

· Build an effective team,assess team performance.

· Make staffing decisions for the area of responsibility.

· Administer reward and recognition programs.,Negotiate internally and externally to secure resources.

· Resolves conflicts affecting productivity and work expectations within the team.

· Frequent external contacts with customers to obtain information and resolve problems.

· Interact with peers in and within other cross-functional groups., Troubleshoots: Reviews quality metrics (e.g.,trend analysis) to identity gaps between current and desired performance.

· Sorts through product related issues (internal/ external), identifies contributing factors and facilitates resolution or reviews and interprets laws and regulations to identify gaps between current and desired compliance., Prepares and Manages Budgets: Establishes departmental or functional budgets, plans against approved budgets, provides cost justifications, and monitors progress against budgets.

· Makes day-to-day decisions which demonstrate a basic understanding of the financial impact on the business drivers (e.g.,ROl, factory costs) and their inter-relationships., Evaluates Risk Levels: Assess risks within established parameters, recognizes when risks associated with decisions exceed limits and escalate, seeks approval when issues remain unresolved.

· Recognizes and Quantifies Risk: Recognizes risk relative to product performance and takes appropriate actions, considers relative risks in processes and procedures and takes appropriate action.

· Quantifies Risk: Identifies and quantifies the financial considerations associated with decisions., Fosters Change: Communicates need for change, helps others understand the need for change and drives that understanding through the organization.

· Makes Decisions: Bases decisions on the overall good, rather than on benefit to a particular functional area, serves as a champion for specific projects and initiatives. Participates as a Team Member: Actively contributes to the team process,commits to team goals,expresses opinions and shares ideas freely.

· Contributes to the creation of the team's mission, objectives, and strategies accepts team decisions and works toward their implementation.

Minimum Qualifications:

• Bachelor's degree, preferably in a science, engineering or life/physical sciences.
• Experience in Quality Assurance: At least 5 years in a QA Role / Compliance / Quality Systems or closely related position in a federally regulated industry.

Preferred Qualifications

• Demonstrated leadership experience through formal and/or informal assignments is preferred.
• Knowledge of regulations and standards affecting IVDs and Biologics.
• Thorough knowledge of manufacturing processes and quality assurance principles; Understanding of the elements of the Quality System Regulation / ISO 13485 / CMDR as well as plant, division and corporate quality/operational system requirements.
• Results-driven.
• Ability to successfully interact and communicate with all organizational levels internally and externally (e.g. suppliers or external regulatory bodies).
• Demonstrated ability to manage several activities / projects at once, organize / prioritize work.