Quality Systems Specialist

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description:

•    Support and drives Quality System Management activities (Document Control, Training, CAPA, Complaint, Change Control, Planned Deviation, Supplier Management, Audit Management, Management Review, etc.)
•    Support business unit with client audits, ISO audits, and FDA inspections
•    Identifies opportunities, leads, and facilitates decision making based on risk and business impact.  Implements Quality, Compliance, Operational or other NAMSA continuous improvement projects and initiatives with global multifunctional teams.
•    Perform as lead auditor for both Supplier Quality Audits & Internal Quality systems audits. Duties including but not limited to scheduling, audit performance, following up with other functional areas on Nonconformance’s, CAPAs and bringing them to resolution and minimize compliance risk.
•    Provides quality/compliance or systems training to others beyond the quality group.
•    Continuous process Improvement. Determines and implements solutions to continuously improve the quality system (e.g. training, mentoring in supporting  Quality systems,)
•    Experience with ISO 9001 or similar quality system standard/regulation (e.g. ISO 13485, ISO 27001, 21 CFR 210/211, 21 CFR 820, etc.)
•    Able to support quality system activities
•    Other duties as assigned.

Qualifications & Technical Competencies:

•    Bachelor’s degree or equivalent experience in a related field, with a  minimum of 3 years of relevant experience
  •    Quality System Compliance experience
  •    Fluency in English and local language, if different
  •    Audit Certification is preferred, e.g. ASQ CQA, ASQ CBA, etc.
  •    Knowledge and experience with Quality System standards and regulations
  •    Ability to assess/audit compliance of Quality Systems to applicable standards and regulations.

*Pay range: $60k-70k*

Working Conditions:

•    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. 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 or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds (12 kg). Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
•    Extensive use of a computer keyboard.
 

Pay Range Minimum:

$56,000.00

Pay Range Target:

$70,000.00

Pay Frequency:

Annual

Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.