Program Manager, Quality Systems

Merit Medical Systems, Inc.•South Jordan, UT

5d•Onsite

About The Position

This position manages and is responsible for managing the VIP program at Merit. This includes but is not limited to timely completion of projects that meet or exceeds its performance goals. Provides compliance guidance and quality operational support for manufacturing or distribution operations, services, and systems. Collaborates with Quality management to recommend, design and implement functional process improvements. Develops, establishes, and maintains quality methodologies, systems, and practices that meet company, customer, and regulatory requirements. This position will interact with and mentor internal cross functional groups as well as external customers.

Requirements

Education and/or experience equivalent to a bachelor’s degree in a scientific/engineering discipline.
Eight (8) years of job relevant experience.
Demonstrated computer skills, preferably spreadsheet, word processing, database, and other applicable software programs.
Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per Global QA objectives.
Demonstrated ability to independently function in a fast-paced environment while moving multiple simultaneous projects forward.
Demonstrated working knowledge of 21 CFR 820, ISO 13485, and other medical device related standards.

Nice To Haves

Medical device industry knowledge strongly preferred.
Certified Quality Auditor or Certified Quality Engineer by ASQ.
Technical writing skills.

Responsibilities

Manages VIP Program for Merit Medical and multiple core business improvement projects to assure timely delivery of new or improved processes which meet user needs.
Creates, tracks, and meets project schedules, plans, and budgets across multiple Merit sites.
May act as project leader or oversee project leader activities.
Monitors work performed by assigned department staff and assists staff in working on team projects.
Proactively and continuously improves internal systems and processes with a quality mindset.
Acts as a subject matter expert (SME) and supports operational quality issues for manufacturing or distribution sites as applicable.
Develops reports and conducts compilation of information for site and functional management.
Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes.
Understands and adheres to current Quality System Regulations and all applicable regional regulations.
Supports document updates and reviews. Communicates impact and drives resolutions with the stakeholders.
Understands, interprets, and applies documentation control principles and processes to ensure compliance with the global quality system.
Performs other related duties and tasks as required.