Quality Assurance Analyst

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its 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

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

Reporting to the Director of QA (TPCQ- Medical Device) , the position will support the Quality Management System and provide strong leadership in the 3 rd party medical device Quality function amongst peers, ensuring that functional activities are aligned with overall company goals and strategies.

These activities include working closely with the company's 3 rd party medical device manufacturers and internal stakeholders to ensure compliance with appropriate regulatory requirements for all targeted commercial markets. These manufactures primarily include third-party contractors, and service/supply vendors but may wholly owned facilities be encompassing medical devices and combination products as applicable to the portfolio in scope. .

YOU ARE more than just a title, YOU ARE...

A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

• Support interactions with regulatory authorities to ensure compliance with regulations associated with activities involving commercial product supply chain.
• Review and approve changes made to product and processes managed by third party medical devices and combination products, suppliers.
• Work with third party suppliers to ensure that non-conformances and deviations are accurately documented, reviewed and approved.
• Support Device Investigation Lab in Irvine conducting accurate returned device investigations and device history record reviews where required.
• Support R&D by representing third party quality for new product development, new region expansion, or a manufacturing product line extension to ensure that the appropriate external manufacturing facilities and process are in place to support commercialization and the supply chain.
• Review and approve technical/validation protocol and reports.
• Develop and maintain effective relationships and integrate activities with other departments and suppliers.
• Support the development and updates to the Risk Management Files for medical device and combination products for third party products.

Qualifications

You Bring

• Bachelor's degree in engineering, physical or life sciences with a minimum of 5-10 years' experience in the medical device field with experience in medical regulations.
• Proven experience working with medical device companies' Quality Management Systems.
• Experience reviewing and approving production drawings, shop orders, and documentation (including structuring bill of materials).
• Computer literate experience; use of word processing, spreadsheets, complaint handling and change control systems.
• Expertise in cGMP's, guidelines, and regulations applicable to the FDA and comparable international regulatory agencies.
• Expertise in ISO 13485 experience in Medical Device's.
• Experience working with product and process validations.
• Experience working with medical device suppliers including review of non-conforming materials, CAPAs, audit finding etc.
• Experience in sterility and packaging requirements for medical devices.
• The ability to recognize problems and take corrective measures.

In this role, we're looking for a leader who will :

• Act as an Owner
• Be Excellence Focused
• Act as an Influencer

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.