Quality Manager

Full-time

SoftWave TRT

Position Overview:
The Quality Manager will lead the company’s Quality Management System (QMS) and compliance infrastructure to ensure ongoing adherence to applicable medical device quality and regulatory requirements, including ISO 13485 and FDA Quality System Regulations / QMSR.
This role will own the quality system framework, supplier quality oversight, CAPA administration, audit readiness, and regulatory support activities, while working cross-functionally with Operations, Engineering, Regulatory Affairs, and Service teams.
The Quality Manager will serve as the primary owner of the company’s quality system governance, ensuring that processes, records, and corrective actions are maintained in a state of continuous compliance and audit readiness.
This role is critical to maintaining the company’s regulatory credibility, audit readiness, and quality system integrity as SoftWave scales. The position ensures the company maintains a strong compliance backbone while enabling growth and operational execution.
Responsibilities:
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Quality Management System (QMS) Ownership
Own and maintain the company’s QMS in alignment with applicable medical device standards
Develop, implement, and maintain procedures, SOPs, work instructions, and quality records
Manage document control, revision control, and training documentation processes
Ensure continuous audit readiness across all quality system elements
CAPA Ownership
Lead the Corrective and Preventive Action (CAPA) system
Ensure timely initiation, investigation, root cause analysis, and closure of CAPAs
Verify effectiveness of corrective actions
Drive cross-functional accountability for issue resolution and process improvement
Supplier Quality Oversight
Lead supplier qualification and quality oversight activities
Establish supplier quality agreements and quality performance metrics
Manage supplier corrective action requests (SCARs)
Conduct supplier quality reviews and support supplier audits
Partner with Supply Chain and Operations on supplier performance and issue resolution
Audit Leadership
Lead internal audit planning and execution
Serve as primary quality lead for external audits, customer audits, and certification audits
Coordinate responses to audit findings and corrective actions
Maintain audit schedules, records, and follow-up activities
Regulatory; Compliance Support
Support Regulatory Affairs with submission documentation and compliance records
Maintain quality documentation required for FDA and ISO compliance
Support inspection readiness and regulatory audit responses
Ensure quality system documentation supports product lifecycle and change control activities
Change Control; Quality Records
Manage engineering change control and quality record processes
Ensure traceability of revisions, approvals, and controlled documentation
Support design transfer and sustaining engineering changes from a quality systems perspective
Performance Accountability - This role is accountable for:
QMS compliance status
CAPA cycle time and effectiveness
supplier quality performance
audit readiness and audit outcomes
documentation accuracy and traceability
quality system process compliance
Cross-Functional Interfaces - The Quality Manager will work closely with:
VP Operations
Director of Technical Operations
Regulatory Affairs
Engineering
Supply Chain / Procurement
Service Operations
Qualifications:
Required:
Bachelor’s degree in Engineering, Life Sciences, Quality, Operations, or a related technical field
Equivalent relevant experience may be considered in lieu of degree
Advanced degree is a plus, but not typically required
Experience
7+ years of progressive quality experience in a regulated manufacturing environment
3+ years in medical device, diagnostics, or other highly regulated industry strongly preferred
Prior experience owning or administering a Quality Management System (QMS)
Demonstrated experience with CAPA, audits, supplier quality, and document control
Experience supporting FDA inspections and ISO 13485 certification audits
Prior startup or early-stage company experience strongly preferred
Technical / Functional Qualifications:
Strong working knowledge of:o ISO 13485o 21 CFR Part 820 / FDA QMSR
CAPA systems
document control
training records
change control
supplier quality systems
audit management
Experience leading:
internal audits
external audits
supplier audits
corrective action programs
Experience with:
supplier qualification and SCARs
nonconformance and deviation management
root cause analysis
effectiveness checks
Preferred:
Experience with electromechanical medical devices or capital equipment
Familiarity with risk management / ISO 14971
Working knowledge of design controls
Experience partnering with Regulatory Affairs on submissions and inspections
Experience implementing or improving electronic QMS systems (eQMS)
Physical Requirements:
Sitting, standing and walking, which may be for extended periods of time
Lifting and carrying, up to 100 lbs
Pushing, pulling, and reaching overhead
Manipulation of objects and materials, including holding, grasping, turning, and touching
Driving
Stooping, crouching, kneeling
Climbing ladders or stairs
Hearing, in-person and through the telephone or electronic device (such as a computer)
Speaking, in-person and through the telephone or electronic device (such as a tablet or computer)
Visual acuity, both near (i.e. clarity of vision of approximately 20 inches or less) and far (i.e. clarity of
vision of approximately 20 feet or more)
Regular and predictable attendance
The responsibilities outlined in this job description are intended to describe the general nature and level of work performed by individuals assigned to this role. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required. Management reserves the right to amend and change responsibilities to meet organizational needs as necessary.
SoftWave TRT is an equal opportunity employer. We make employment decisions solely based on business needs, job requirements, and individual qualifications without regard to race, gender, religion, ethnicity, age, or any other

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Vacancy posted a month ago

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