10000 Talent manager Jobs

Purpose

The Senior Quality Analyst (“Analyst”) is part of AbbVie’s Medical Device Center within the Shared Services function (“MDCSS”).  The Medical Device Center manages quality activities across a variety of medical devices and combination products, varying from U.S. Class I to Class III (and international equivalents); the Shared Services function serves in an above plant capacity with core emphasis on Product Life Cycle Management and related ancillary functions.  This position’s primary focus is on management of Design History Files (DHFs) and related change control activities, and reports into a departmental manager.

§  The Analyst must have worked in the Medical Device Industry and understand related regulations to effectively perform this role.  This means the Analyst must have exposure to 21 CFR 820, ISO 13485, and EU MDR 2017/745 or MDD 93/42/EEC.

o   Note:  Strong candidates with 2-5 years of Medical Device experience may be considered for a lower Analyst role.

 §  Design Control Knowledge.  Exposure to CFR 21 CFR 820.30 is mandatory since the Analyst must understand how design control works.

§  Change Control Experience.  Understanding the various facets of change control and how these release to design control is a core job responsibility.  The Analyst will be an SME in this area.

§  Detailed & Organized.  This role will coordinate and champion change control activities, therefore it’s important that the Analyst thinks about and addresses scenarios which could possibly affect the success of change activities. 

§  Strong Writing Skills.  The role will write justifications and explain changes, therefore the ability to write coherently is critical.

§  Tech Savvy.  This role will include coordinating activities in multiple Life Cycle Management Platforms, so you must have sufficient skills to navigate basic IT Platforms.  (e.g., TrackWise, Polarion, Veeva, etc.)

This position will be responsible for maintaining and updating the DHF of assigned on-market medical devices and combination products.  This entails ensuring that required activities for change management have been correctly assessed and potential impacts addressed.  The Analyst is expected to have in-depth knowledge of each product’s DHF, DHF elements, know where to find information within it, and raise and lead the effort to correct any deficits.  The ideal candidate is detail-oriented, enjoys strategic planning, enjoys reading & writing, and is comfortable advocating for doing what is correct over what is easiest. 

• Bachelor’s degree with 6 years’ experience experience working with medical devices or medical device components (e.g., ISO 13485, ISO 9001) including experience working in CAPA or Design Control, Post-Market Reporting.
• Direct experience working in CAPA, Design Control, Post-Market Reporting
• Working knowledge of 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971
• Working knowledge of Design Control per 21 CFR 820.30
• Working knowledge of CAPA Tools, including 5-Whys, Ishikawa, etc.
• Working knowledge of tools/statistics used for data analysis (e.g., Pareto charts, histograms, etc.)
• Strong analytical skills
• Strong attention to detail
• The ability to recognize problems and take corrective measures
• Analytical, organized, with strong multitasking abilities
• Fluent in verbal and written English