This position is responsible for assisting with the implementation of best practices to optimize
quality, efficiency & productivity in systems throughout our facilities. This
position is responsible for the execution of Internal Audit activities and administration of the Internal
Audit process in accordance with Company procedures. This position will interface with individuals
at all levels of the organization to conduct audits at specified intervals report audit findings,
facilitate and monitor the life cycle of audit findings until completion. This position promotes
continuous improvement of systems, products, and services, by managing and supporting global
external regulatory compliance inspections, responses, and action implementation follow up. This
position is responsible for analyzing and monitoring quality data to identify potential issues and
implement necessary actions to mitigate compliance and product risks.
This position will provide guidance to assist in the development, implementation, and maintenance
of the Quality Management Systems to ensure the organization functions effectively and efficiently
in order to ensure a high level of Regulatory Compliance and to achieve Company goals,
objectives, and policies as well as satisfy customer requirements.
strong computer skills, including proficiency with Word, Excel, and PowerPoint
o Knowledge of national and international regulations applicable to medical devices
including FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR (Canada Medical
Device Regulations, MDD (European), EU MDR requirements, etc.
o Apply effective time management, critical thinking, problem solving and collaborative
approaches to improving the internal audit program
o Excellent communication skills and the ability to express ideas both orally and in written
form.
o Demonstrated understanding of industry regulations, including detailed knowledge of
FDA QMS and ISO 13485
o Well organized and accustomed to maintaining quality/cGMP compliant records
o strong ability to work with team members across functions/departments.
o Demonstrated ability to effectively present information to top management and team
members.
o Demonstrated ability to identify priorities and function independently required.
o Ability to analyze situations thoroughly, identify potential problems, find, and implement
effective solutions.
o Background Experience
o BS in Engineering or Science (Life Sciences preferred) or equivalent combination of
education and work experience required
o Requires 5 years work experience in Quality/Compliance within a regulated industry.
TMC is an Equal Opportunity Employer Page 3
o Requires5 years' work experience in Quality System Auditing (CQA ASQ certification or
ISO Lead Audit certification or experience as a regulatory agency auditor/inspector is
required).
o Minimum 2 years work experience leading an audit for the medical device industry
o Certified Quality Auditor (CQA) certification (ISO 13485 or EUMDR lead auditor
certification, preferred
location: Elkton, Maryland
job type: Permanent
salary: $120,000 - 130,000 per year
work hours: 8am to 5pm
education: Bachelors
responsibilities:
Leads and supports quality system audits to ensure the QMS operates in a state of
compliance and continuous improvement; prepare audit reports and conduct audit briefings
upon completion of audits within specified timeframes and generate audit corrective action
requests as applicable.
2. Monitor internal audit non-conformances, perform trend analyses, and present findings.
3. Contribute to the development and improvement of audit program metrics.
4. Contribute to the development of the internal audit schedule
5. Provide support for the Business' internal and external audit compliance strategies.
6. Implement changes to the Quality System procedures/forms as needed to maintain
compliance, improve effectiveness and efficiency.
7. Facilitate the Internal Audit Program
8. Responsible for the timely completion of the audit schedule
9. Interface with FDA and third-party auditors during inspections, as needed.
10.Provide support to 3rd Inspections (front room/back room)
11.Monitor and remain current with internal company procedures/policies, International QS
standards and federal regulations.
12.Participate in process improvement activities to continuously improve process effectiveness.
13.Assist in compliance training and mentoring of auditors
qualifications:
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
