- Acts as the representative for the Quality Assurance Department, catering to clients across various sectors including biotechnology, pharmaceuticals, food, and aerospace. Ensures customer requirements are understood and met, manages feedback and complaints, and implements corrective actions as needed.
- Responsible for developing and managing an ongoing quality management program that ensures the company's products and services are fit for purpose, consistent, and compliant with Scientific Calibration Standard Operating Procedures (SOPs), Client Specifications, and both external and internal regulatory requirements.
- Regularly monitors the Electronic Document Management system through internal audits. Manages document control processes including creation, review, approval, distribution, and revision, ensuring all documentation is up-to-date and accessible to relevant personnel.
- Leads investigations into quality-related incidents, non-conformances, and customer complaints. Gathers and analyzes relevant data to identify root causes.
- Oversees proficiency testing plan analysis, risk assessments, and competency evaluations. Ensures that proficiency testing data adheres to established quality control procedures and protocols, verifying the accuracy and precision of test results using internal quality control materials.
- Maintains compliance with regulatory standards such as ISO/IEC 17025:2017, ISO 8655:2022, and ISO 9001:2015.
- Reviews reporting certificates and qualification documentation to ensure accuracy and compliance with both regulatory and customer requirements.
- Works closely with other departments to identify improvement opportunities and implement solutions.
- Establish and effectively communicate key performance indicators (KPIs) for quality management.
- Develops safety policies, procedures, and guidelines in accordance with local regulations and industry standards. Implements safety programs to prevent accidents, injuries, and occupational hazards. Works competently and safely with potentially infectious materials, following all prescribed OSHA guidelines and maintaining required documentation and logs.
- Demonstrates innovative leadership and acts as a role model for all other team members.
- The ability to communicate clearly and professionally through both oral written channels.
- Exceptional work organization and time management.
- Strong computer skills essential of Microsoft Office and databases.
- Exceptional numerical skills and understanding of data analysis/ statistical methods.
- Knowledgeable of quality management systems and principles, as well as quality and statistical report preparation.
- Certification of Quality Control is a strong advantage.
- Paid Time Off (80 hours year one; 160 hours max)
- 13 Paid Holidays per year
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability insurance
- 401(k)
- 401(k) matching
- Tuition reimbursement
- Employee discounts
- Retirement plan
- Monday to Friday
- 8:00 AM - 5:00 PM
- In office Position
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Quality Assurance Manager - Cary, United States - Scientific Calibration Inc.
Description
Job Description
Job DescriptionWe are seeking a Quality Assurance Manager to become an integral part of our team
Job Summary
The Quality Manager is responsible for ensuring that the products and services provided by the company meet both external and internal requirements, including regulatory compliance and customer expectations. This role involves overseeing the implementation and maintenance of the quality management system, leading continuous improvement initiatives, and managing the quality assurance team.
Role and Responsibilities
Qualifications and Education Requirements
BS/BA Degree in a life science, healthcare, or quality management discipline, or previous 3-5 years equivalent education or experience in a similar biological sciences or related discipline. Minimum of 3-year experience in quality assurance/management position.
Preferred Skills
Benefits
Schedule
