1+ months

Sr. QA Professional - Design QA

Green Oaks, IL 60048

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.

Primary Job Function:

Responsible for implementing and maintaining the effectiveness of the quality system.

Design Control:  Able to define design document requirements for process and test method validation.

Guides and influences new product teams through design; validation; and regulatory compliance and assures robust product vs. customer requirements.

Documentation & Change Control:  Assesses the impact of a change on field performance and customer expectations world-wide.  Understands and assesses the impact of a change on the safety and efficacy of a device.

Corrective & Preventative Action:  Uses technical depth; in process; and test methods to assist in preventative action.  Analyzes impact of failure within and across product lines.  Able to assure actions are taken to prevent reoccurrence.

Regulatory:  Analyzes and justifies the impact on cumulative changes and the impact of a change across other products.  Assess FDA submission requirements on changes.

Quality System:  Maintains and ensures compliance to the quality system that is appropriate for the unit specific medical device(s) designed or manufactured. Ensures compliance to and is able to demonstrate knowledge of site level policies and procedures.

Technical:  Advanced understanding of process and test method validation.  Able to relate information to specifications; clinical utility; product claims and design.  Teaches team members customer communication skills (written and verbal).  Reviews technical literature and shares key publications.  Communicates opportunities for learning (i.e.; technical meeting; quality system conferences). Uses clinical knowledge; understanding of competitor's products; and extrapolation from limited data bases to assure fitness for use. Drafts letters for customer notifications/recalls.  Demonstrates project management skills.  Understands the impact of testing and process variation on manufacturability and field performance.  Proficient at risk management.

Core Job Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.

Has a comprehensive understanding and broad technical base of instrument platforms across product lines.  Able to support products that have significant ($100MM) business impact. Has an in-depth knowledge and understanding of specification setting and is able to guide new product teams and other quality team members through the process.  Has a comprehensive knowledge of a variety of technologies; qualitative or quantitative. Is able to analyze and summarize complex data packages.  Understands and can defend impact of changes as they relate to the regulatory environment.  Is able to manage multiple and/or complex projects and priorities. Reviews and has knowledge of key literature supporting clinical applications.  Has exposure to clinical or technical leaders. 

Participates as new product team member and is able to elevate and resolve critical issues.  Provides direction and influences team.  Trains others on the theoretical and practical basis of techniques; processes and assays.  Prepares & aligns impact goals with department goals.  Establishes project plans; updates and contributes to product or experimental design.  Provides input into strategic goals and identifies and elevates gaps in current goals.  Sets standards and provides performance feedback.; Participates and influences outcome. Able to resolve conflict between team members.  Communicates with customers on complex technical issues.  Provides advanced technical leadership and guidance to project and cross functional teams.  Frequently interacts with external customers.; Manages problem solving and resolution process.  Understands the global implication of failure being investigated.  Identifies resolution to prevent occurrence of same or like occurrences.  Able to draft complex Customer Communications regarding product notification.  Understands relationship between product processes; specification and field performance.  Able to establish meaningful and predictive test methods.  Extrapolates beyond test protocols and conclusions based on limited data bases.  Assesses limitations imposed by test design.  Understands applications and basic theoretical concepts of multiple technologies (for example; MEIA; CMEIA).  Understands and distinguishes quantitative vs qualitative assays.; Makes plans to accomplish multiple activities/projects; establishes priorities to meet multiple demands; optimizes use of resources.  Works on developing and improving new planning processes.  Implements project plans using resource; budget; and regulatory requirements to meet project goals.;

Quality: Understands and meets current quality requirements to promote conformance to customer; regulatory and divisional requirements.

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.

Supports Organizational Change:  Helps drive and promote understanding of the need for change through the organization.  While doing so; shares and clarifies business strategy.

Influences Outcomes:  Appropriately influences others to support a course of action; uses authority; influences activities without reliance on formal authority; removes barriers that block goal attainment; drives change through the organization; and communicates unpopular decisions in a realistic and supportive manner based on available information.

Identifies Self Development Needs: Translates changes in business goals and objectives into the skills; knowledge and experience needed for future work; and establishes appropriate development goals.

Surfaces Problems/Presents Ideas for Resolution:   Highlights issues and presents possible resolutions.   Identifies and reports problems in a timely and accurate basis and seeks additional information when problem is beyond area of personal expertise.  Takes personal responsibility to resolve issues.

Evaluates Risk Levels: Recommends actions and develops responses to cope with various scenarios.; Translates product performance and customer feedback on current products; evaluates clinical and technical trends; and applies these to continuous improvement to new product requirements and new test methods.

Translates Business Strategy:  Translates external and internal customer requirements and ADD goals into the day-to-day activities necessary to accomplish them. Incorporates the requirements and expectations of both external and internal customers; as well as the Division's objectives; into daily activities and personal goals

Anticipates Future Directions: Identifies quality and regulatory trends to contribute to the development of long-term business strategies; anticipates future directions in customer needs and scientific advances and provides input to the appropriate business areas.  Familiar with competitors' systems; and performance on QC surveys.  Participates with Marketing and Sales organizations to support and leverage business strategy.; 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.  Provides 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.;

Coaches:  Provides on-the-job guidance; instruction/mentoring; and training.

Resolves Conflicts:  Directly confronts rather than avoids conflicts; depersonalizes conflict situations by focusing on issues rather than personalities and actively searches for win-win solutions.

Supports the work group:  Takes the initiative to ensure that the work required of the group is accomplished; works with other members of the department to ensure smooth; effective and efficient operation; willingly helps peers by covering for meetings and other events.

Participates as a Team member:  Contributes to the creation of the team's mission; objectives and strategies; accepts team decisions; works toward their implementation and displays sensitivity to group dynamics.

Facilitates Team Activities:  Establishes meeting agenda; facilitates meetings; collects input from all team members.; Adapts Information to Customer Needs:  Adjusts communication style and medium (verbal; written; or electronic) to meet the needs of the receiver; summarizes data; uses appropriate level of language and detail for the receiver. Provides accurate and complete information.

Advanced Written Communication:  Writes customer communication letters and effectively summarizes level three failure investigation with close supervision.

Makes Key Presentations:  Delivers persuasive and motivational presentations to influence employees; peers; customers; regulatory agencies; and/or senior management. Articulates and translates department and/or functional strategy and objectives.  Identifies and elevates when legal; public affairs; and risk management needs to be contacted for field issues.

Position Accountability / Scope:

Provides direction and strategy for specification setting and validation of new products.  Obtains consultation from ADD Regulatory Affairs on complicated product changes. Makes independent decisions within defined parameters regarding fitness for use; field actions; document approval; etc.; assuring these decisions are compliant with site level policies and procedures and aligned with the appropriate quality system.  Project goals are broadly defined; defines project milestones; responsible for timely project completion.  Drafts; reviews and publishes customer letters.  Identifies critical issues; solutions; and presents alternatives.


Minimum Education:

Associate Degree; preferably in a life science; physical science or technology field; with at least 10 years experience in a clinical laboratory; diagnostic quality or technical area; or Bachelors Degree; preferably in a life science; physical science or technology field; with at least 7 years experience in a clinical laboratory; diagnostic quality or technical area; or Masters Degree; preferably in a life science or physical science; with a minimum of 5 years experience in a clinical laboratory; diagnostic quality or technical area; or closely related field or sufficient related and transferable experience. Knowledge of regulations and standards affecting IVDs and Biologics is preferred. Above average skills in Microsoft Word, Excel, and PowerPoint.  Certification is a plus (such as ASQ). Experience in Design Control and new product development preferred.

Minimum Experience / Training Required:

Years of experience depends on Education; candidate may be brought in at lower grade commensurate with educational/professional experience.
Job Family: Operations Quality
Division: ADD Diagnostics
Travel: Yes, 10 % of the Time
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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Sr. QA Professional - Design QA

Green Oaks, IL 60048

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Green Oaks, IL

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