What are the responsibilities and job description for the Quality Systems Specialist position at Three Point Solutions?
Job Description
Job Description
Job title : Quality Systems Spec
Client : Medical Device Manufacturing Company
Duration : 2.5 months
Location : Louisville, KY 40219
Quality Systems Spec
Experience
3 - 5 Years
Technical Skills
Must Have
Regulatory Knowledge - FDA 21 CFR, ISO 13485
Nice To Have
Knowledge of SAP or other Inventory Management System
Quality auditing experience
Job Description
HM's Top Needs :
Experience working in Quality for minimum 2 years
Experience with CAPA, Root Cause Analysis tools and Auditing
Ability to work independently since this person will be at a 3PL site as the MDT quality rep.
Education Required :
Bachelors
Years' Experience Required : 2
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 decision-making.
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.
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Quality Systems Specialist?
Sign up to receive alerts about other jobs on the Quality Systems Specialist career path by checking the boxes next to the positions that interest you.
