Quality Systems Program Mgr - Exempt

Must Have:


15+ years of experience in medical device industry
Bachelors Degree in Engineering
Project Management, 21CFR820, FDA, ISO 13485, QMS, Medical Device industry


Nice to Have:


Masters Degree
Project Management certificates


JOB DESCRIPTION
Spotlight Call with HM:
1/17 @ 1pm CST
+***,
Phone conference ID: 305 820 283#

Target BR: ***/hr

HM's Top Needs:
1. Medical Device industry experience (15+ years)
2. QMS, Inspection Readiness
3. Project Management


Experience project manager in the medical device industry, responsible for the inspection readiness program and QMS related projects at Diabetes.
Strong knowledge and experience dealing with regulatory requirements and standards including 21CFR820 and ISO 13485:2016.
Expected bachelor's degree, preferable in engineering.
Master's degree preferred.
Years' Experience Required: +15
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes
Work Location:
Do they need to be local to any MDT office and if so where? Preferred in Northridge, CA
Does this person need to be on site? If so, full time or part time? Preferred in Northridge, CA but remote candidates would be considered.

Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.


Leads inspection readiness program, coordinates resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.


Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets.


Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties . Modifies programs management processes to improve program. Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management. Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.


Requires a Bacherlor degree, Master degree preferred.
Requires at least 15 years of experience in medical device industry, which needs to include project management.