Quality Inspector

BayOne Solutions; Sturtevant (WI); On-site; USD 65,000 - 95,000; Full time

Job summary

BayOne Solutions is seeking a QA professional to ensure compliant documentation for medical device history records and to release finished products after final QA review.

The role involves identifying nonconformances, initiating NCAs, and maintaining quality systems and training records. Collaboration with manufacturing and cross-functional teams is required to drive continuous improvement.

Qualifications

• Experience with medical device quality systems preferred.
• Knowledge of regulatory requirements (FDA 21 CFR Part 820, ISO 13485) is a plus.
• Ability to interpret SOPs and apply to daily tasks.

Responsibilities

• Ensure timely QA review of documentation to verify compliance to SOP’s and regulatory requirements.
• Perform final review and release of finished Medical Device History Records.
• Identify and initiate NCA for nonconformance found during the final review of DHR’s.
• Maintain expertise in quality systems (e.g. assist and review SOP’s, initiate change control)
• Ensure training requirements are met and records are up to date.
• Maintain and update departmental metrics and required reports.
• Assist with continuous improvement initiatives / projects within the Manufacturing and Quality departments.
• Create and maintain the Product Conformance Certificates specific to client.
• Work closely with the Manufacturing Depts to provide on-going Quality support. Represent QA at cross-functional meetings, providing input and decision making.
• Assist with Incoming Inspections, returns and training duties
• This job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job. The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time.

Skills

Attention to detail

Regulatory awareness

Documentation skills

Education

Bachelor's degree in Life Sciences or Engineering

Tools

Quality Management System (QMS)

Job description

• Ensure timely QA review of documentation to verify compliance to SOP’s and regulatory requirements.
• Perform final review and release of finished Medical Device History Records.
• Identify and initiate NCA for nonconformance found during the final review of DHR’s.
• Maintain expertise in quality systems (e.g. assist and review SOP’s, initiate change control)
• Ensure training requirements are met and records are up to date.
• Maintain and update departmental metrics and required reports.
• Assist with continuous improvement initiatives / projects within the Manufacturing and Quality departments.
• Create and maintain the Product Conformance Certificates specific to client.
• Work closely with the Manufacturing Depts to provide on-going Quality support. Represent QA at cross-functional meetings, providing input and decision making.
• Assist with Incoming Inspections, returns and training duties
• This job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job. The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time.