Skip to main content

This job has expired

You will need to login before you can apply for a job.

Associate Director, Device R&D Quality

Employer
AbbVie
Location
Pleasanton, California
Start date
Jun 29, 2021

View more

Discipline
Quality, Quality Control, Science/R&D, Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

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.

The Associate Director, R&D Device Quality will support the development of medical devices and/or device components of combination products by providing direction on applicable design control, human factors/usability engineering, and risk management processes.  This position will engage with all areas involved in the product development process and provide direction and consultation assuring the design control system is effectively established, executed, and maintained.  This position will participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, and development of the risk management plans.  This role may have direct reports supporting medical device product development efforts.

 

Key Roles and Responsibilites

Technical Support

Design Control Activities:

  • Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Control Process. 
  • Responsible for Quality Engineering deliverables required within the product development process.
  • Support Design Verification and Validation activities, including review of verification & validation protocols and reports
  • Assist in the analysis of product requirements and specifications. Participate in product design reviews and team meetings.
  • Provide subject expertise and input in the following areas: Biocompatibility strategy, including requirements, protocol, and report; Shelf-Life Studies strategy, including accelerated and real-time; Cleaning Validation.
  • Implement Design Control process improvements to ensure a more effective, efficient, and compliant design control process.
  • DHF Audits throughout the development process
  • Development of Quality Plans
  • Maintain and Manage the DHF after product commercial release

Risk Management Activities:

  • Maintain and manage the overall ZELTIQ Risk Management process in accordance with ISO 14791 and other applicable standards. Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure a comprehensive risk management process.
  • Implement New Risk Management Process, Procedures, and Templates and help migrate and update current risk management documents to new process.
  • Manage Post-Market Surveillance and Feedback into Risk Management

Usability Activities:

  • Implement new Usability Process, Procedure and Templates and provide support to the transition to new Usability processes.
  • Provide quality support for the Usability plan, report, and file.

Project/ Process Management

  • Provides clear and regular technical and administrative direction to personnel assigned to a project.  Requires broad perspective of company, regulatory and site policies and procedures, in addition to personal representation and leadership abilities.
  • Facilitates and leads design and reliability activities related to Design, Manufacturability, and Reliability (DRM) practices.  This includes planning, leading, facilitating, and supporting activities such as robust engineering, reliability predictions, capability analysis, development of CTQ's, VOC, requirements flow down, etc.

Quality System

  • Ensures that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
  • Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals and Medical Devices worldwide.
  • Interprets regulations and trends and recommends/executes changes to quality standards to ensure conformance and continuous improvement

People Management

  • Experience with managing and coaching R&D quality engineers Product Lifecycle Management process, Design Controls, Design Changes, CAPA and Nonconformance resolution, Quality Plan and Quality Agreement generation, Verification and Validation activities, and Clinical Quality oversight.
  • Participates in cross-functional meetings/initiatives and sets and maintains the standards for interdepartmental actions and the integration of quality planning with development and operations planning.
  • Performs administrative functions including performance management, goals and objective setting and personal development planning. Assures short term training needs for local staff are addressed, and longer-term individual and organizational development needs are identified, planned, and implemented.

Qualifications

Qualifications/Experience

  • 10+ years’ experience working in the Medical Device industry; 5+ years’ experience working in project and/or people management
  • Minimum of a BS in Engineering or Scientific discipline; MS preferred
  • Thorough knowledge of Medical Device development activities
  • Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry – Quality Risk Management, 21 CFR 4 Regulation of Combination Products, SOR 98-282 Canadian Medical Device Regulation, ISO 14971 Risk Management Standard, MDD, IEC/EN 62366 Application of Usability Engineering to Medical Devices, IEC 60601  Medical electrical equipment, and ANSI HE75 Human Factors Engineering in Design of Medical Devices
  • Skilled in requirements analysis, including testable and measurable specifications
  • Strong experience with reliability analysis and test methods and test method validation
  • Excellent verbal (including presentation) and written communication skills, especially technical report writing
  • Ability to effectively influence others and work within the Allergan organization as well as partnering with external partners
  • Ability to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
  • Experience interacting with regulatory agencies and notified bodies
  • In depth knowledge and experience with corrective action and preventive action system, statistical process control, quality risk management, FMEA, DOE and other key tools for managing quality performance.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.

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
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert