Quality Assurance Specialist

Objective

Under general direction, will provide onsite support in quality systems activities to assist in meeting company objectives and quality systems requirements.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

1. Assist Quality Management in establishing, implementing and maintaining the quality management system.
2. Review daily feedback, including customer complaints, non-conforming reports, Supplier quality issues, etc., and assess the need for Corrective Actions, including CAPA, reporting to Regulatory Authorities, post market surveillance and risk mitigation update.
3. Review, update and monitor quality systems documentation (i.e. quality plans, post market surveillance, etc.) and maintain corresponding logs.
4. Summarize monthly customer feedback, quality related activities, coordinate with engineering and report findings to Quality Manager.
5. Conduct internal quality audits.
6. Coordinate calibration and environmental monitoring activities, summarize and report findings to Quality Manager.
7. Verify quality documentation to ensure accuracy.
8. Assist in the collaboration of production and quality control to resolve in-house quality concerns.
9. Maintain work area in a clean and orderly fashion.
10. Adhere to company and departmental policies and practices as well as ISO, safety, and security measures.

Additional Duties and Responsibilities include the following. Other duties may be assigned.

1. Continually look for ways to improve processes, procedures and/or products; evaluating and participating in improvements as appropriate.
2. Occasional travel to attend training / meetings or conduct Internal /Supplier Audits, as needed.
3. Generate reports and reconcile information.
4. Provide accurate and complete information in a prompt manner.
5. Other projects or tasks as assigned.

Supervisory Responsibilities

This position has no supervisory responsibilities.

Education and/or Experience

Bachelor’s degree from a four-year college or university in a scientific field and 2 to 4 years related experience. Previous medical device quality experience is desirable.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.

Language Skills

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to complete forms accurately and write routine notes and documentation. Ability to effectively communicate information in one-on-one situations to other employees of the organization.

Mathematical Skills

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Computer Skills

Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.

Certificates, Licenses, Registrations

None required.

Knowledge, Skills, and Abilities

Knowledge of FDA GMPs, ISO 13485, MDSAP

Knowledge of medical device manufacturing or a related field.

Ability to communicate effectively, orally and in writing, with employees of various disciplines within various departments and all other internal and external contacts.

Ability to be flexible in changing daily workload priorities as directed and accurately perform detail- oriented work.

Ability to work independently and demonstrate strong organizational, follow-through and resolution skills.

Ability to maintain accuracy, consistency and quality in a fast-paced, multi-task environment.

Ability to coordinate and synchronize multiple projects.

Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk; hear; sit; use hands to finger and handle; bend at the waist and/or neck use one or both hands repetitively; use fine manipulation with one or both hands and to reach above or below shoulder level. The employee is occasionally required to stand; walk; twist at the waist or neck use a simple grasp with one or both hands; and lift and/or move up to 50 pounds. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is moderately quiet.

The posted range for this position is $66,037-$90,802 annually which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.

Clinician's Choice, A division of DenMat Holdings, offers a complete benefits package, including Medical/Dental/Vision/Rx, Company Paid and Optional Life Insurance, 401(k) with matching contribution, Vacation, Sick Pay 10 paid company Holidays (or Float Days), Bereavement, Jury Duty Pay, Employee Assistance Program and employee discounts.

Clinician's Choice, A division of DenMat Holding participates in E-Verify.

DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer; employment with DenMat is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, creed, national origin/ethnicity, veteran status, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital status, or any other legally protected status.