Quality Specialist

3 weeks ago

Scarborough, United States Abbott Laboratories Full time

About Abbott

Abbott Rapid Diagnostics is part of Abbottâs Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The Quality Specialist â Post Market Surveillance is part of the Quality Compliance group, and is responsible to identify, review and assess the impact of world-wide product manufacturing, quality, regulatory or safety issues that arise in complaint investigations, manufacturing deviations, trend analysis or other non-conformities related to products sold by ID.

The Opportunity

This position analyzes quality system and business data to generate Management Review and Post Market Surveillance reports and/or presentations. This will include detailed data reports (e.g. graphs, charts, tables) prepared for routine monthly and quarterly trending, senior management reviews, ad-hoc requests, and cross-functional requests as needed (e.g. Regulatory, Quality Engineering, R&D). Coordinates with area owners to gather, analyze and report Quality and business metrics and KPIs. Responsible for adherence to Good Manufacturing Practices (GMPs). Communicates results of analysis via reports and written communications, as appropriate.

RESPONSIBILITIES:

  • Apply knowledge, as related to product application, to evaluate product risk management and postmarket surveillance activities. 
  • Prepare monthly, quarterly, semi-annual, or ad-hoc reports for management review, postmarket surveillance or other activities as required.
  • Prepare and maintain postmarket surveillance plans..
  • Initiate and facilitate non-conformances as a result of postmarket surveillance activities..
  • Support internal and external inspections by preparing relevant reports
  • Coordinate the development and modification of postmarket surveillance reports with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
  • Manage multiple projects while maintaining timelines
  • Be vigilant of unusual trends and communicate them to management
  • Participate on project teams related to divisional/enterprise postmarket surveillance, as requested
  • Represent team by collaborating with other team members, and departments needing management review or postmarket surveillance information
  • Complies with U.S. Food and Drug Administration (FDA) regulations, In vitro Diagnostic Regulation (IVDR), other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
  • Demonstrate basic project management skills by acting as a project lead on small, well defined projects.
  • Plans, organizes, and prioritizes own daily work routine to meet established schedule.
  • Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources.
  • Responsible for corporate deliverables, as required.

BASIC QUALIFICATIONS | EDUCATION:

  • Bachelors Degree (± 16 years); or equivalent combination of education and experience.
  • Minimum 2-5 years of related work experience with a good understanding of specified functional area.
  • Working knowledge and application of business concepts, procedures and practices.
  • Will perform this job in a quality system environment.
  • Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment.
  • Working knowledge of process controls, validations and qualification methods, statistical applications, and quality systems is required.
  • Must have working knowledge of GMP and ISO, and experience representing the company directly with Regulatory bodies.

PREFERRED QUALIFICATIONS:

  • Experience working in a broader enterprise/cross division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to travel, including international.

COMPETENCIES:

  • Knowledge of Database software; Design software; Internet software and Word Processing software.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. 
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 
  • Ability to write speeches and articles for publication that conform to prescribed style and format. 
  • Ability to effectively present information to top management, public groups, and/or boards of directors.
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. 
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.



The base pay for this position is $48,000.00 â $96,000.00. In specific locations, the pay range may vary from the range posted.

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