Job Description
Job Description
Job Description
CS Medical
Job Title: Quality Assurance Manager
Department or Division: Quality
Reports To: Director of QA and RA
JOB TASKS, DUTIES, AND RESPONSIBILITIES
The Quality Assurance Manager is responsible for helping to execute and improve the Quality Management System to the requirements of the FDA’s QMSR and ISO 13485. The Quality Assurance Manager participates in the company’s complaint program including analysis of complaint trends and determination of corrective actions (CAPA). The Quality Assurance Manager also helps define metrics; their purpose, source data, and leading the analysis to determine if metrics are being achieved.
The Quality Assurance Manager collaborates with the different departments to ensure the company maintains quality compliance with the QMSR and ISO standards. The Quality Assurance Manager maintains and improves reports of quality data to aid in CS Medical interactions with regulators and customers to represent the company’s products and processes.
The Quality Assurance Manager also manages a team of QC and QA technicians to ensure quality of in-process testing and final acceptance testing along with analysis of complaint and other quality data.
JOB DUTIES:
- Helps execute and improve the Quality Management System.
- Helps define metrics, purpose, source, analysis methods, sets alert / action limits with clearly documented rationales.
- Is assigned special projects for Quality Assurance to execute in supporting Research and Development of new products.
- Supports interactions with regulators, auditors, and customers to represent the company products and processes.
- Keeps the Risk Management Files up to date and accurate per ISO 14971.
- Improving, implementing, and validating electronic record systems.
- Ensures that personnel, who perform tests and inspections, are trained to the documented procedures.
- Reviews non-conforming reports created by the company and ensures timely closures.
- Analyzing complaints that need investigation.
- Creates CAPAs and brings them through the entire CAPA process.
- Quality Objective data is collected, analyzed and reviewed by the QA Manager.
- Ensures that only repaired units passing final acceptance testing leave the company for clinical use.
- Performs other quality duties as required.
- Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
- Maintain the department as to follow CS Medical’s QMS and adheres to FDA QMSR and ISO 13485.
- Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale.
- Ensures compliance with design controls and design documentation to ensure regulatory requirements are met.
MINIMUM QUALIFICATIONS
- Excellent written and oral communication skills.
- Strong Documentation skills.
- Must have experience writing procedures and work instructions.
- Ability to be both hands on and to lead.
- Strong analytical and problem-solving skills, including solid understanding of internal and applicable external policies, procedures and standards.
- A four-year degree or equivalent
- Strong skills being able to work with, and performing validation of, electronic records
- 5+ years of broad quality system/regulated environment experience.
- Working knowledge of applicable standards and regulations including FDA CFR and ISO 13485
- Experience in leading a small team of people.
PREFERRED QUALIFICATIONS
- A four-year degree or equivalent with a BS in science or engineering
- ASQ Certification or other quality certifications are desirable
- ComplianceQuest electronic quality system management experience
Accountabilities
- Special Projects assigned for Quality Assurance to support Research and Development is completed.
- Communication and relationship with other departments is one of mutual respect and cooperation.
- Timely execution of CAPAs.
- Quality Objectives recorded quarterly.
- The Quality Management System is improved over time.
- Helps in 510(k) premarket notifications, EU Technical Files, Health Canada Submissions, and other international submissions.
LOCATION
This position will be based at our Creedmoor, NC office.
Terms of employment
This is a full-time, salaried, exempt position.
HOURS
The general hours shall be Monday – Friday, 8:00am to 5:00pm with an hour break for lunch.
Work Environment
Work is regularly performed in office and warehouse environments.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is frequently required to sit. The employee is occasionally required to stand and/or walk. The employee must occasionally lift, carry, push or pull up to 20 pounds.
Travell
Minimal travel may be required.
BENEFITS
Compensation package includes health insurance, dental insurance, vision insurance, short term disability, life insurance and Teladoc following an introductory period. The Company offers a 401K plan with employer contribution. The Company also offers paid time off and paid holidays.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.