Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
ABOUT ABBOTT DIAGNOSTICS:
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life.
Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Our location in Irving, Texas currently has an opportunity for a Manager, Design Quality Software.
WHAT YOU’LL DO
The primary function of the Manager, Design Quality Software is to manage, provide guidance & lead the QA team in all aspects of product design control for On-Market and In-Development activity. The incumbent is responsible for implementing, managing and maintaining the effectiveness of the quality system and is expected to have a firm understanding of the design input, risk management, cyber-security, design verification, design validation and design output/transfer processes & tools as applied to the software product development life-cycle. Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products. This position will be required to manage human resources activities of the team, assign responsibilities and manage performance of a team of Software Quality professionals.
Additional responsibilities include:
- Management – Manage a team of SW Quality professionals to ensure procedures and principles are implemented across the organization. This includes direct management.
- Cyber-security – Maintain awareness of cyber-security regulations and changes and incorporate into the software processes. Also responsible for ensuring the Software QA team is aware and promoting cyber-security principles in all aspects of SW development. Will also interact with corporate process teams.
- Design/Change Control - Software responsibilities include managing a team in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
- Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc.
- Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates and provides guidance in the development, modification and design review of Protocols, Data Summaries & Records.
- Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.
- Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
- Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management. Keeps current with industry software best practices.
- Quality Engineering – Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.
- Decision-Making: Comprehends the implications & consequences of how proposed changes and project demands will affect both internal & external customers.
EDUCATION AND EXPERIENCE YOU’LL BRING
- B.S. in Computer Science; Software Engineering; Biomedical Engineering; Life Science or closely related discipline is required or relevant combination of education & experience; MS is preferred.
- 10+ years’ experience covering the entire design control process in a team-oriented environment.
- 3+ years experience in direct responsibility for management of human resources experience is preferred.
- Prefer tool experience with HP Quality Center, Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS.
- Knowledgeable of FDA 21 CFR 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485/14971 guidelines, IEC 62304, 21 CFR Part 11, and international Cyber-security regulations/guidance.
- Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices is a plus.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a dynamic & fast-paced environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with on-boarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.