10 days old

Sr Quality Assurance Professional

Abbott
Abbott Park, Illinois

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

The Senior Professional Quality Assurance is responsible for implementing and maintaining the effectiveness of the quality system. Additional responsibilities include:

  • Design Control:  Develops and implements new product design plans to assure low cost; robust specifications; reproducibility; and high-quality products that meet customer expectations.
  • Documentation & Change Control:  Understands and assesses the impact of changes on validation and manufacturability of a product.  Analyzes data and draws conclusions.  Assesses the impact of changes on product stability and dating.  Able to identify critical parameters which define optimal reagents; primaries; panels; and references to assure consistent product performance across lots.
  • Corrective & Preventative Action: Identifies issues and guides teams to understand the root cause and resolution.
  • Regulatory: Assesses the regulatory risk associated with change documents; defends rationale and compliance to internal and external auditors.
  • 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.
  • Quality System:  Understands; implements; and maintains the quality policy. Ensures compliance to and is able to demonstrate knowledge of site level policies and procedures.
  • Technical:  Reviews and analyzes data; draws effective conclusions.  Understands experimental design. Can apply knowledge to data analysis and problem-solving situation. Working application of statistical tools (SPC; DOE; Basic Stats; ANOVA). Utilizes comprehensive process knowledge and detailed understanding of multiple technologies in failure analysis; specification setting; and product development/improvement.  Applies statistical tools; data analysis methods; knowledge of clinical applications; and technical writing skills to address failure analysis; spec. setting; and product development/improvement.  Understands the consequences of product issues on product performance; customer acceptance; customer risk; compliance; and manufacturability.   Proficient at Hazard Analysis. Applies creative technique to problem solving and issue resolution.  Understands the impact of testing and process variation on manufacturability and field performance.

    Core Job Responsibilities:

    The Professional IV, Quality Assurance is responsible for implementing and maintaining the effectiveness of the quality system. Position scope includes:

    • Has an in-depth understanding of diagnostic products; processes and technologies.  Is able to support multiple products and projects.
    • Utilizes statistical tools to analyze data.
    • Understands multiple technologies and instrument platforms. 
    • Knows both qualitative and quantitative products.  Is aware of competitor's products perceived strengths and weaknesses.  
    • Understands quality control procedures and manufacturing processes for final product.
    • Has an in-depth understanding of; and can assess justifications on change documents. 
    • Must be able to identify issues; assess risk; make recommendations; and elevate issues as required.  Has knowledge of clinical applications for products for which they are responsible.
    • Understands intended use and off-label uses of products. 
    • Responsible for implementing and maintaining the effectiveness of the quality system.; Participates as a new product team member and is able to identify and elevate critical issues.
    • Trains others and troubleshoots problems; may lead others in project teams.
    • Participates with team and assures favorable outcome. 
    • Interfaces in customer communication on basic performance issues. 
    • Participates in project and cross functional teams. 
    • Occasionally will interact with federal agency representatives and other external customers.
    • Draws conclusion from analysis and recommends a course of action. 
    • Judges whether technical design of experiments are sufficient to answer the question being asked. 
    • Identifies root cause through use of problem-solving skills. 
    • Functional application of statistical tools.  Functional knowledge of product reference assignment. 
    • Applies problem solving skills to wide variety of problems:  failure investigation; product specifications and product design. 
    • Establishes and executes against project goals and implements plans.

      Additional Scope Includes:

      • Fosters Change:   Communicates and helps others understand the need for change.; 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.
      • Quantifies Risk: Identifies and quantifies risk relative to the success of an overall project; takes appropriate actions and elevates to the appropriate level.; 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
      • Monitors Trends: Demonstrates awareness of changes in the quality and regulatory environment; as well as science; industry; competitors and companies.  Aware of competitors' products perceived strengths and weaknesses.; 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.; Coaches:  Provides on-the-job guidance; instruction; 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.
      • 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:

        • Assures new product robustness and manufacturability vs customer expectations.
        • Receives general direction and exercises considerable discretion as to work detail. 
        • Contributes to the definition and timely achievement of overall project goals. 
        • Assures activities are consistent with project critical path; the quality policy and compliant with site level policies and procedures.
        •  Identifies and elevates critical issues and recommends possible solutions.

          Minimum Requirements:

          • Bachelor’s Degree; preferable in the life or physical sciences or closely related field or sufficient related and transferable experience.
          • 5 years of experience in a quality or technical area; or clinical laboratory 
          • Knowledge of regulations and standards affecting IVDs and Biologics is preferred.

            Preferred Experience:

            • Experience in Design Control, assay file development and new product development preferred.
            • Medical device or in-vitro diagnostics experience strongly desired
            • Experience with site audits highly preferred
            • Experience and proficiency with Microsoft applications (Word, Excel, Powerpoint etc)

              ","industry":"HealthcareDivision: ADD Diagnostics
              Travel: Yes, 5 % of the Time
              Medical Surveillance: Not Applicable
              Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2020-05-20 Expires: 2020-06-19

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Sr Quality Assurance Professional

Abbott
Abbott Park, Illinois

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