Mgr, Laboratory Incoming Medical Devices

at  AbbVie

Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description

EDUCATION

• Bachelor’s degree in electrical, mechanical, electronic, electromechanical engineering or bachelor’s degree in biotechnology, chemistry, computer science, materials or industrial engineering with certifications or experience in electrical, mechanical or electromechanical field.
• English 80%

EXPERIENCE

• 5 year of experience in regulated industries with expertise as supervisor of quality technician teams or incoming laboratories.
• Experience as Supplier/Internal Auditor is a plus.

SKILLS

• Root cause determination tools, such as DMAIC or A3, among others.
• Advanced knowledge of Office applications (Windows)
• Ability to communicate written and oral ideas in a clear, concise and precise manner.
• Critical thinking and continous improvement.
• Negotiating.
• Quality Management Systems/regulations. (GMPs, QSR, FDA, ISO, CAPA).
  Additional Information
  AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
  US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
  US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
  https://www.abbvie.com/join-us/reasonable-accommodations.htm

PURPOSE STATEMENT

• Manage Incoming Laboratory department to assure achivement of company objectives and regulatory requirements compliance.
• Ensuring that quality relevant material suppliers provide materials that meet AbbVie specifications and defects level to avoid interruptions in the supply of raw materials to the production floor and customer complaints associated with materials.
• Provide the tools and guidance necessary for the development and growth of the different members of the team.

MAJOR RESPONSIBILITIES

• Establish, coordinate and follow up departmental objectives and other activities, as well as resolve conflicts and work in coordination with other departments to assure achivement of company objectives.
• Support the review and approval of NCRs and SCARS activities related to the area of supplier quality and incoming inspection.
• Track blocked (rejected) materials to comply with the process and the respective goals or metrics.
• Assure that incoming tests are performed per applicable procedures with adequate equipment/instruments and technical documentation such as a valid test method, qualified laboratoy equipment or a recognized standard.
• Support and execute activities related to projects of assurance of supply, new product introduction, transfer products or process, sustaining and qualification of suppliers, supply change notifications.
• Evaluate the impact of changes for incoming and supplier qualification processess in the change control system to define aduequate actions and change plan; also be a SME assessor for those process in the change control system.
• Review, approve and close change control plans and actions.
• Manage the budget (including CER) for the Incoming laboratory department.
• All other duties inherent to the position and those assigned by his/her immediate supervisor, including deviations, NC’s, CAPAS, DCC’s, CCs, AIAs, CFT & CRB meetings, TRs, VALs, IRFs and internal audit responses.
  Qualifications