Quality Manager
Job Summary
Design Hire is seeking a Quality Manager to lead quality systems inspection activity and compliance efforts within a regulated manufacturing environment. This role is a strong fit for someone with hands-on quality leadership experience who can improve processes support audits and maintain high standards across production and documentation.
Key Responsibilities
Manage quality management activities across inspection documentation corrective actions and process controls.
Lead internal audit readiness and support external regulatory or customer audits.
Oversee quality inspection processes to ensure products meet specifications standards and release requirements.
Partner with operations engineering and production teams to resolve quality issues and improve manufacturing performance.
Maintain and improve procedures records training and quality system documentation.
Qualifications
5 years of quality experience in a manufacturing environment preferred.
Prior quality leadership or management experience required.
Medical device manufacturing experience strongly preferred.
Working knowledge of FDA audit requirements and regulated quality systems.
Experience with ISO 13485 preferred.
Background supporting fabrication processes inspection methods and production quality controls.
Strong understanding of corrective actions root cause analysis nonconformance handling and documentation practices.
Strong communication organization accountability and cross-functional leadership skills.
Equal Employment Opportunity Statement
Design Hire is proud to be an Equal Employment Opportunity / Affirmative Action employer. It is our policy to consider for employment all individuals regardless of age color national origin citizenship status physical or mental disability race religion gender sex sexual orientation gender identity and/or expression genetic information veteran status or any other characteristic protected by federal state or local law.
Employment Eligibility: If hired a Form I-9 Employment Eligibility Verification must be completed at the start of employment. Temporary work authorization or the need for sponsorship may disqualify you from employment.
Required Skills:
Quality Management Medical Device Quality inspection FDA audits ISO 13485 fabrication processes
Required Education:
BA