Quality Assurance Specialist

Quality Engineer (Medical Devices)
Job Title: Quality Assurance Engineer
Job Function: Ensure Quality Standards
Job Type: Contract to Perm/Perm
Location: Onsite - Portsmouth NH Area
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Responsibility for all controlled documentation; drawings, procedures, production routers, product structures, customer drawings and any other documents under revision control.
• Responsible for administering the Document Change Order (DCO) system and coordinate the preparation and review of DCO's.
• Maintain records related to document change orders, ensure they are up to date and adequately controlled.
• Perform clerical duties, including:
• Filing, document retrieval, updating documents and organizing documents.
• Interface with the Production and Quality control to ensure all document updates are correct and clear.
• Understanding of design and drafting standards required for the check and release of engineering drawings utilizing AutoCAD.
• Enforce departmental and companywide ISO, cGDP, and cGMP requirements.
• Responsible for configuration management including Device Master Records, revision control/history, product structure development and maintenance, documentation release to production.
• Standards regulation including the adherence to and update of industry standards.
• Assist in verification of both equipment and/or manufacturing processes.
• Assist with Quality Control job functions when needed.
• Equipment calibration and maintenance: keeps up to date records on equipment calibrations and assist in coordination of calibration schedules.
• Environmental control monitoring. Monitoring and organization of controlled environment factors such as particulate and bio-burden levels. Maintains records of environmental testing to ensure they are up to date and adequately controlled.
• Perform NC and CAPA activities, writing, managing process and ownership.
• Perform complaint handling and record and file per MVI SOPs, FDA, MDD requirements.
• Assist Quality Team with other QA related job functions.

Competencies

• Technical Capacity.
• Learning Orientation.
• Time Management.
• Thoroughness.
• QMS systems
• Inspections
• Document Control
• cGMP Medical Device Manufacturing
• cGDP Medical Device Manufacturing
• Working knowledge of ISO 13485 at latest revision

Supervisory Responsibility
This job has no supervisory responsibility.

Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment.

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.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bending or standing on a stool as necessary.

Position Type/Expected Hours of Work
This is a full time position with the core hours being during production of 7:00 a.m. to 3:30 p.m.

Travel
Travel is minimal and less than 10%.

Requirements
Required Education and Experience

• High School Diploma
• 5 years of experience in a quality manufacturing environment.
• GMP experience.
• Experience in document control, utilizing AutoCAD, Solid Works, ERP or MRP experience is a plus.
• Microsoft Office skills.

Preferred Education and Experience

• Four year degree
• Five plus years of experience

Equal Employment Opportunity Statement
Our Client provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Other Duties
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.


RCMTechnologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.

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Last updated on Apr 30, 2023