Quality Manager

SoftWave TRT

Marietta, GA

Apply

JOB DETAILS

JOB TYPE

Full-time

SKILLS

Auditing, Biology, Capital Equipment, Change Control, Change Management, Code of Federal Regulations, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Document Control, Document Management, Electromechanics, Engineering Management, External Audit, FDA (Food and Drug Administration), FDA Requirements, Healthcare Quality, ISO (International Organization for Standardization), Internal Audit, Leadership, Lift/Move 100 Pounds, Maintain Compliance, Manufacturing, Medical Diagnosis, Medical Equipment, Medical Protocols, Performance Metrics, Physical Demands, Problem Solving Skills, Procedure Implementation, Process Improvement, Product Documentation, Product Lifecycle, Product Support, Purchasing/Procurement, Quality Control, Quality Management, Quality Metrics, Regulations, Regulatory Requirements, Regulatory Submissions, Risk Management, Root Cause Analysis, Sales Qualification, Source Code/Configuration Management (SCM), Standard Operating Procedures (SOP), Startup, Supply Chain, Supply Chain Operations, Support Documentation, Tablet PC, Technical Operations, Time Management, Traceability, Vendor/Supplier Evaluation, Vendor/Supplier Management

LOCATION

Marietta, GA

POSTED

27 days ago

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

About the Company

SoftWave TRT

Resume Resources

Free Resume Templates Free Resume Builder