Manages day-to-day implementation and maintenance of the Quality Control system. Plans, coordinates & directs quality program designed to ensure quality control and quality assurance of the production of products consistent with established standards & regulatory guidelines. Manages teams that conduct product release, customer complaints, documentation, nonconforming material, management review trending, and quality and process engineering.
Duties & Responsibilities:
- Product release: review all pre and post production testing when alert levels have been reached or product fails. Initiate further testing for decision making. Review repeated devices.
- Customer Complaints: Review all completed customer complaints for acceptability. Ensure appropriate reporting of MDR/recall events.
- Documentation: Implement and maintain an effective system for document and record control. Ensure procedures are sufficient for effective operation and applicable regulations and standards requirements. Approve all documents. Initiate system related documentation or updates to current documentation.
- Nonconforming Material: As nonconforming issues arise, determine disposition with Material Review Board. Direct departmental resources to take corrective action. Approve Nonconforming Material Reports (NMR's), Temporary Deviations (TDN's) and Rework Instructions.
- Management Review: Compile quality data to generate trend reports for quality indicators and inform management of these trends quarterly. Ensure the quality system requirements are maintained and report on the overall performance of the quality system to management for review and to provide information for improvement of the quality system.
- Manages employees in the Quality Engineering and Technical Services Departments.
- Responsible for the overall management, coordination, and evaluation of these units.
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Responsibilities include but are not limited to interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance and behavior and encouraging growth and development.
- Provide input for any new launches or process and product changes, and align operational needs & capabilities with all departments, including R&D, validations & reagents, quality, and project teams.
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Requirements:
- Ability to inspire quality engineering team to foster engagement, belonging, and growth.
- Ability to align quality engineering team to deliver activities that support the overall company vision and direction.
- Proficiency with document tools (Word, Excel, document control programs including Master Control) and ERP systems.
- Personal investment in self-awareness, curiosity, and problem-solving skills.
- Ability to coach & develop people leaders to model successful performance and behavior and inspire teams to perform and behave successfully
- Requires a B.S. in a related field with 7-10 years' experience.
Application Window closes 2/28/2025
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
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