Abbott Supervisor Quality Assurance, PQA in Irving, Texas
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Supervisor role responsible for PQA/complaint team supporting hardware and software for the Dallas site. Subject matter expert for the complaint and PQA processes for Dallas hardware/software team.
Primary Job Function:
Responsible for implementing and maintaining the effectiveness of the quality system.
Manage the direct activities of an area within a department or function. Provides direct supervision to professional, direct or indirect labor staff. Insure that plans are implemented and milestones are achieved. Ensures that compliance is maintained and that employees are trained and following the required site level policies and procedures.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Gather and prepare trend information and recommend areas of focus.
Assist in the preparation of the financial plan; gather financial and other data to support the plan.
Assist in the development of the capital plan by identifying projects to improve processes, reduce costs, and maintain operations.
Sets standards and monitors staff performance; provide performance feedback; write and conduct appraisals for employees, recommend merit increases and promotions, deliver rewards and sanctions. Responsible for implementing and maintaining the effectiveness of the quality system.; Regularly makes decisions which impact quality, time and/ or cost; timely decisions are required regarding issues such as to proceed or abort, work OT, etc. Manages assigned projects; work cross functionally to identify changes and necessary resources. Develop and recommend departmental reward and recognition programs. Assist employees in the creation of development plans; work with employees to meet their development needs. Establish the motivational climate for the group. Communicate work center/ department objectives and results. Uses time effectively, both for self and others; identifies appropriate meeting participants and uses meetings effectively. Coach teams; provide guidance, direction, training, resources, and time.; Direct supervision of work force. Create a climate of trust and respect within the group. Exchanges information with employees, peers, and management regarding operations. Conducts individual discussions with employees, including performance reviews, development, discipline, and staffing interviews. Interviews candidates for positions on the direct staff. Interact with peers in operations and within other cross-functional groups. Responds directly to on-site requests for information from internal and external regulatory agencies.; Troubleshoots: Tracks and reviews daily indices (e.g., line outputs, labor efficiency, reject rates) and regulatory requirements to identity gaps between current and desired performance, applies standard problem solving tools (e.g., fish bone diagrams, Pareto analysis), recommends and implements corrective action so that the impact of the problem is minimized. Interfaces with other areas to identify and solve problems.; Utilizes Financial Information: Makes day-to-day decisions which demonstrate a basic understanding of the financial business drivers (e.g., ROl, factory costs, cost reductions) and their inter-relationships.; Recognizes Risk: Recognizes risk relative to procedures and takes appropriate action.
Quantifies Risk: Identifies and quantifies the financial, quality, regulatory, and human considerations associated with decisions.; 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.
Embraces Change: Adapts to and supports change in a timely, positive manner. Identifies and communicates need for change.; Participates as a Team Member: Contributes to the creation of the team's mission, objectives, and strategies, accepts team decisions and works toward their implementation.
Participates as a Team Leader: Establishes and supports the norms and conditions for a work environment that supports team productivity, draws on the strengths of each team member, seeks input of team members, works cross functionally to resolve issues.; Improves Processes: Utilizes information from seminars, bench marking, focus groups, etc., to identify trends and generate recommendations for continuous process improvements in such areas as reduced costs, new technologies, and reject rates.; Makes Decisions: Utilizes good judgment and makes timely decisions which consider the facts and data at hand; champions specific projects; knows when to escalate to management.
Builds Relationships: Follows through on promises and commitments and maintains confidences.
Manages Personal Effectiveness: Controls emotional reactions; copes with stress; is open to others' ideas; demonstrates an understanding and appreciation of differences in others; treats others as individuals with unique skills, interests and values; seeks to understand the goals and needs of others.
Motivates Others: Promotes productivity and morale by treating others with respect and dignity. Listens to different points of view, taking ownership and responsibility for own actions. Displays consistency between words and actions; follows through on commitments; is available to answer questions. Provide constructive feedback on individual and team accomplishments in a timely and non-threatening manner.
Confronts Issues: Raises issues that block the achievement of individual and team performance; voices opinions and concerns without waiting to be asked; communicates through areas of difference as well as areas of common issues, i.e., can talk about both sides of an issue.; Solve Customer Problems: Lead teams to customer oriented solutions that make business sense.; Stays Current: Demonstrates awareness of the changing competitive, technological, health care, and regulatory environments, and demonstrates a perspective beyond one's own function.; Coaches Direct Reports: Provides on-the-job guidance, instruction, training, and resources.; Plans Activity Structure: Makes plans to accomplish assigned daily activities and simple projects; establishes priorities so as to handle competing demands; optimizes use of available resources; estimates time and resources necessary to complete daily tasks or projects; establishes follow up systems.; Creates a Motivational Environment: Promotes productivity and morale by treating others with respect and dignity, listening to different points of view, taking ownership and responsibility for own actions, modeling the behavior expected of others, following through on commitments, being available to answer questions, providing positive feedback on individual and team accomplishments, and providing developmental feedback in a timely and non-defensive manner.
Confronts Issues: Raises issues that block the achievement of individual and team performance, voices opinions and concerns without waiting to be asked, and attempts to establish areas of difference as well as areas of common interest. Actively promotes conflict resolution.
Influences Outcomes: Influences others to support a course of action and to incorporate quality concepts in all activities, appropriately uses authority, influences activities without reliance on formal authority, and communicates unpopular decisions in a realistic but favorable light.; Makes Decisions: Makes timely decisions which consider the facts and data at hand; champions specific projects; knows when to delegate to teams or other levels.; Adapts Information to Customer Needs: Adjusts communication style and medium (oral, written, or electronic) to meet the needs of the receiver (direct reports, peers, customers, managers); summarizes data and distills it down to relevant points to enhance understanding; uses appropriate level of language and detail for the receiver.
Provides Information: Shares information with appropriate frequency and timeliness so as to benefit the receiver; keeps parties potentially affected by decisions apprised of events; presents information to internal groups and meetings; conducts technical training for internal and external groups.
Assimilates Information: Uses questioning and listening skills to collect and share information.
Position Accountability / Scope:
Represent the function to other areas of the company and outside the company. Ensure that employees are trained and the appropriate procedures are followed.
Maintain GMP's or other compliance requirements; monitor work environment to determine if it is in compliance.
Identify and implement cost reductions.
Provide budget recommendations; perform cost reduction and variance analysis
Coordinate day to day activities; crew/schedule work centers, expedite and resolve day to day issues. May oversee multiple shift operations.
Raise issues to the appropriate level for resolution.
Knowledge of regulations and standards affecting IVDs and Biologics.
BS or equivalent and 2-4 years of related operations experience. Experience should demonstrate the application of analytical and mathematical skills, and the ability to understand financial information or directly technical experience sufficient to demonstrate the knowledge typically associated with the degree and experience requirement. Knowledge of regulations and standards affecting IVDs and Biologics.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org