Senior QA Leader: Regulated Manufacturing & QMS Audits

Rise Technical; Detroit (MI); On-site; USD 160,000 - 180,000; Full time

Benefits offered by this job

Profit Sharing (10%)

Tuition Reimbursement

Udemy courses

On-site role

Development opportunities

Job summary

Rise Technical is seeking a Senior Quality Assurance Manager for an on-site role near Detroit, MI. You will own the Quality Management System, drive CAPA and validation, and lead audits and regulatory compliance across the site.

You will partner with cross-functional leaders and manage a QA team in a regulated manufacturing environment (ISO 13485 / FDA 21 CFR Part 820), delivering continuous improvement and long-term development within a stable, growing manufacturer.

Qualifications

• Leadership experience in QA within regulated manufacturing.
• Experience with CAPA, audits and validation in a QA system.
• Experience leading cross-functional teams.

Responsibilities

• Lead the site Quality Management System (QMS) development and continual improvement.
• Drive CAPA and validation activities.
• Represent the site in external audits and regulatory bodies.
• Partner with cross-functional leaders and QA team.

Skills

QA leadership

Regulated manufacturing

CAPA management

Audits & validation

Cross-functional leadership

Job description

Rise Technical is seeking a Senior Quality Assurance Manager for an on-site role near Detroit, MI. You will own the Quality Management System, drive CAPA and validation, and lead audits and regulatory compliance across the site.

You will partner with cross-functional leaders and manage a QA team in a regulated manufacturing environment (ISO 13485 / FDA 21 CFR Part 820), delivering continuous improvement and long-term development within a stable, growing manufacturer.