Manager, Global Quality Systems
Our medical device client who is going through expansion is looking for a Manager, Global Quality Systems for their Pittsburgh, PA operation who would be responsible to develop quality assurance strategies to support the growth of the Hemostasis product line and drive operational excellence initiatives to improve year over year the productivity.
Job Summary:
The candidate will drive quality initiatives to improve the overall quality of the product portfolio through Design, Manufacturing, and Post-Market activities. Develop in concert with R&D, Manufacturing Engineering, Operations, and Business Unit Partners a Total Cost of Quality mindset for assessing and addressing priority issues.
Manages multiple Global Quality Systems functions including but not limited to:
- Non-Conforming Events, Corrective and Preventive Actions (CAPA), Training; Document Control, Management Controls including Management review and Quality Planning
- Quality Systems Metrics and Trending including Global Key Performance Indicators (KPIs)
Primary Responsibilities:
- Applies systems level experience and project management skills where analysis requires a broad review of both technical and business factors.
- Effectively manages the deployment of business strategies, the utilization of personnel, and the scope and timeliness of responses. Builds strategic relationships to further Quality organizational objectives and collaborates with all levels in executing quality objectives.
- Works to achieve the overall objectives of the company and ensures that quality strategies are aligned for the areas of responsibility.
- Transforms Engineering and Business needs into tactical quality action plans; defines key capabilities, quality requirements, and key constraints of programs.
- Oversees the quality system compliance through Global Key Performance Indicators to monitor performance of key elements of the quality system.
- Assists management with objective evaluation of overall the Global Quality System performance and provides guidance for implementation of improvements, corrective and preventive actions for related quality processes.
- Works with management to ensure the effective implementation and maintenance of Quality System requirements and procedures, to domestic and international regulations and standards.
- Works cross-functionally, interacts with management across the company or with external entities on a variety of diverse and broad scope issues where analysis requires the review of technical, quality, logistics, and business factors.
- Executes on the Quality System strategy and facilitates implementation ensuring financial, technical design, quality, and project management accountability for resources and results; Achieve the goals and objectives within financial limits.
- Participates in 2nd party agreements (e.g. contract manufacturing, distribution, acquisitions, etc.) through due diligence activities of quality system assessment, contractual agreement, and quality system integration.
- The candidate will carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include
- Interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Qualifications:
- Bachelor’s Degree in Engineering or Life Sciences.
- 7+ years related quality assurance experience.
- 2+ years managerial experience with proven ability and experience in planning, developing and executing quality initiatives in order to maintain world class QA standards.
- Experience within medical device or pharmaceutical industry (working knowledge of working knowledge of ISO13845:2016, FDA 820 CFR, MDSAP, JPAL, CMDR, MDR, & ANVISA).
- Experience analyzing and summarizing large data set projects using valid statistical practices within the Engineering Quality System, Minitab preferred.
- Analytical chemistry or biochemistry knowledge, preferred.
- Lean auditor certification, preferred.
If interested, please email Earl Callender at ecallender@daleyaa.com
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