Product Quality Engineer - Risk Management
- Employer
- AbbVie
- Location
- Lake County, IL, US
- Start date
- Mar 21, 2019
View more
- Discipline
- Engineering, Marketing, Product Development/Management
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest, Best Places to Work
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Job Details
We currently have an opportunity for a Product Quality Engineer/ Risk Management expert who will ensure support of a broad portfolio of on-market medical device and combination products.
The Quality Engineer will lead from a technical quality perspective the preparation of Risk Management plans/reports, risk management file remediation efforts, review/approval of Design Control documents, support design verification/validation activities, and maintain compliance of product/platform design history files.
This position will be located in our Medical Device Center Headquarters in Waukegan, IL and report into Senior Manager, Operations Quality.
Responsibilities include:
Technical and Behavioral Competencies:
The Quality Engineer will lead from a technical quality perspective the preparation of Risk Management plans/reports, risk management file remediation efforts, review/approval of Design Control documents, support design verification/validation activities, and maintain compliance of product/platform design history files.
This position will be located in our Medical Device Center Headquarters in Waukegan, IL and report into Senior Manager, Operations Quality.
Responsibilities include:
- Ensure compliance with global quality systems and Regulatory requirements such as Design Controls, risk analysis/management tools, investigations, CAPAs, etc. to assure product quality
- Perform Design Control activities; ensure design control documentation and design change control requirements are met and appropriately traced throughout the development process and in the design history file for products such as:
o Electromechanical Infusion Pump
o Container Closure Systems
o Enteral and Infusion Tubing
o Connected Medical Mobile Applications - Drive the creation of an appropriate Risk Management Plan at the start of a project and maintain the plan through all phases of development; support risk assessment activities through UFMEA, DFMEA, PFMEA and other QA risk analysis techniques in order to manage potential risk during development and commercialization
- Advises product teams in a manner to optimize the implementation of risk management strategies for specific risk assessment activities and documents, coordinating and/or authoring documents as appropriate, providing project teams/senior management with a comprehensive recommendation on risk management strategy and remediation.
- Support the sustainability and life cycle management of an existing product.
- PQA point of contact on medical device and combination product development teams and design reviews.
- Provides support for training of team members on design control processes and risk management tools.
- Support manufacturing site inspections/audits for compliance with Design Controls of Combination Products.
Technical and Behavioral Competencies:
- Excellent knowledge of ICH, US & EU regulations and requirements for Risk Management, Medical Device, Combination Product Development & Post-Market Management.
- Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
- Proven ability to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist.
- Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives
- Champions high quality deliverables, innovation, and appropriate risk-taking; Ability to understand the sensitivities within the AbbVie's environment.
- Excellent project management and interpersonal skills
- Bachelor's degree in Science, Engineering, or other technical/scientific areas; ASQ preferred
- 7 plus years of experience in the medical device industry; experience with combination products, infusion pumps and supporting ecosystems preferred
- Design Controls experience and strong knowledge of risk management including generation of system risk documentation.
- Working knowledge of ISO 13485, 141971, 21 CFR 4, 21 CFR 820, and MDD
- Working knowledge of medical device international standards
- Working knowledge of problem solving and statistical methods as applied to process and product quality preferred
- Software Life Cycle Management a plus
Company
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, and YouTube.
Stock Symbol: ABBV
Stock Exchange: NYSE
Company info
- Website
- http://www.abbvie.com/
- Phone
- 1-800-255-5162
- Location
-
1 North Waukegan Road
North Chicago
Illinois
60064
US
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