LabcorpMorrisville, NC, United States
Covance by Lab Corp is currently hiring for a Quality Specialist to join our growing team in Morrisville, North Carolina. The Quality Specialist is responsible, under Director level supervision, for leading, supporting and ensuring continued suitability of the Quality Management System (QMS). *Relocation Assistance available*
Essential Duties and Responsibilities
- Ensure that the Quality System is compliant with domestic and international
quality system regulations (21 CFR 820; ISO 13485).
- Promote awareness of the Quality System and provide training to individuals
across the organization on quality management principles, tools, techniques
and best practices.
- Support the implementation of corporate policies and procedures relating to
quality, design control, risk management, project management, process
development, supplier management and FDA/ISO compliance.
- Engineer solutions to address product and process quality issues. Work as
part of a team to drive forward continual improvement initiatives and address
- Support the research, development and manufacturing of in-vitro diagnostic
(IVD) medical device products. Lead the planning, design, preparation,
execution, reporting, and analysis of design verification and validation efforts
to qualify materials, tools, equipment, systems, processes, and software used
in the testing, processing, manufacturing, storing, and distribution of IVD
- Initiate and coordinate the inspection and testing of raw materials, work-in-
process, finished goods and environmental conditions.
- Design and develop forms, instructions and sampling procedures for
recording, evaluating, and reporting quality and reliability data.
- Manage and maintain design history files, risk management files and device
history records to ensure design and development activities are executed as
- Coordinate and support the Corrective / Preventive Action (CAPA), Change
Control and NCM/MRB systems.
- Support the document control and training system.
- Lead the investigation, reporting, and resolution of customer complaints.
- Conduct supplier audits and partner with suppliers to address Requests for
Supplier Corrective Action (RSCA).
- Coordinate and support the annual audit program; manage, schedule, perform
and report on internal, external and supplier audit activity.
- Compile and report quality metrics. Assess and report post-market
surveillance data in accordance with regulatory requirements.
- Bachelor’s Degree in Biology, Chemistry, Life Sciences or Engineering required,
Master’s Degree preferred.
- At least 3 years of experience in a quality working with ISO 13485
- Note: An advanced degree in Biology, Chemistry or Life Sciences accepted in
lieu of professional experience. - ASQ Certified Quality Engineer and Six Sigma
Black Belt preferred.
- Thorough understanding of quality philosophies, principles, systems, methods,
tools and standards
- Through understanding of customer expectations, supplier relations and
continual improvement practices
- Experienced in acquiring and analyzing process data using appropriate
quantitative and statistical methods across a spectrum of business
environments to facilitate process improvement
- Excellent communication skills
- Excellent writing skills
- Strong organizational skills
- Ability to handle multiple projects simultaneously
- Exhibits self-reliance in managing personal workload and schedule of
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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