Quality Systems Spec - Exempt

Must Have:


CAPA
LMS
QMS
training experience


Nice to Have:


QMS Simplification


JOB DESCRIPTION
**No Spotlight Call**


Target BR: *** ***/hr


HM's Top Needs:
1. Regulated Industry Experience (preferably med device or pharma)
2. Experience managing Quality Mgmt System documents and systems and Learning Mgmt Systems (Training)
3. Ability to manage multiple projects


This role is for a QMS Specialist. This person will be helping out to cover many aspects of the QMS while other team members are helping with a document repository transition. Helping with QMS documentation, LMS (training) systems and assigning training, document control, etc. This role supports a large manufacturing site and a high level of customer service and attention to detail is necessary.
Education Required: bachelor's degree
Years' Experience Required: 3-5 years+
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours per week ( no OT)
Work Location:
Do they need to be local to any MDT office and if so where? - Brooklyn Center, MN
Does this person need to be on site? If so, full time or part time? - part time (flex in office and home - most activities can be done remotely but expect 1-2 days on site per week)

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 standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.


SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).


DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.


Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.