Senior Quality Systems Specialist
About The Position
We are seeking a highly motivated Senior Quality Systems Specialist with a deep understanding of Quality Management Systems (QMS) in regulated industries such as medical devices or aerospace. The ideal candidate brings hands-on experience managing quality systems, strong cross-functional coordination skills, and a keen understanding of how quality processes drive both compliance and continuous improvement. This is a high-visibility role that requires a proactive communicator capable of managing complex quality deliverables while balancing regulatory rigor with business needs. Join our dynamic team and help shape the future of quality excellence in an environment where your expertise will make a meaningful impact every day!
Requirements
- Bachelor’s degree in a relevant discipline (e.g., Engineering, Life Sciences, or related field); or an equivalent combination of education and experience.
- 4–6 years of experience working with Quality Management Systems in regulated industries (e.g., Medical Device, Aerospace, or Industrial Manufacturing)
- Strong working knowledge of relevant standards and regulations , including ISO 13485, FDA 21 CFR Part 820, MDSAP, EU MDR, and/or AS9100.
- Familiarity with planning, conducting, participating or documenting internal audits.
- Hands-on experience managing SCARs, CAPAs, or driving continuous improvement of QMS processes.
- Comfortable using and maintaining a Quality Management System (QMS).
- Excellent written and verbal communication skills, with a proven ability to collaborate effectively across functions and levels.
- Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
Nice To Haves
- Certified Lead Auditor (ISO 13485, ISO 9001, or AS9100).
- Experience supporting third-party or regulatory audits (e.g., FDA, MDSAP, Notified Body).
- Familiarity with training programs, document control, or change management.
- Experience implementing or upgrading eQMS platforms.
Responsibilities
- Maintain and improve Quality Management System processes across applicable sites and business functions.
- Monitor changes to applicable quality and regulatory requirements and coordinate implementation of updates.
- Coordinate and administer the Internal Audit Program, including scheduling, auditor assignments, audit tracking, and corrective action follow-up.
- Support customer, certification body, and regulatory audits, including preparation, hosting activities, and follow-up actions.
- Coordinate responses to audit findings resulting from customer, certification body, and regulatory audits.
- Own and administer the CAPA program, including facilitation of investigations, effectiveness reviews, metrics, and closure activities.
- Support supplier qualification and supplier audit activities as needed.
- Support administration, validation, testing, and continuous improvement of the electronic QMS (eQMS).
- Support document control and change management processes as required.
- Prepare quality metrics, trend analysis, and Management Review inputs.
- Participate in continuous improvement and risk-based quality initiatives.
Benefits
- Competitive Pay: $75,000 - $95,000 per year.
- Company paid holidays
- flexible working schedule through our paid time off (PTO) policy
- 401k plan, which includes an employer matching contribution.
- medical, dental and vision coverage
- company-paid short-term and long-term disability insurance
- company-paid basic life insurance
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
