Quality Manager

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:
Education

• 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
   o CAPA systems
   o document control
   o training records
   o change control
   o supplier quality systems
   o audit management
Experience leading:
   o internal audits
   o external audits
   o supplier audits
   o corrective action programs
Experience with:
   o supplier qualification and SCARs
   o nonconformance and deviation management
   o root cause analysis
   o 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