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The Davis Companies · 1 month ago

Quality Engineer (Medical Device)

United States

Full-time

Remote

Entry, Mid Level

$100K/yr - $115K/yr

2+ years exp

The Davis Companies is seeking a Quality Engineer to enhance their Quality Management System while ensuring compliance with regulatory standards in the medical device sector. The role involves collaborating across teams to support audits, CAPAs, and continuous improvement initiatives, all aimed at maintaining product quality and patient safety.

Property ManagementReal Estate

Growth Opportunities

Hiring Manager

Rich Gardner PHR

Responsibilities

Ensure compliance with applicable regulatory standards and international quality requirements

Develop, implement, and maintain quality documentation, including procedures, work instructions, and records

Support and participate in internal and supplier audits; track and drive closure of audit findings

Collaborate with Regulatory Affairs, R&D, Manufacturing, and Supply Chain to implement corrective and preventive actions and mitigate risk

Provide training on quality procedures, standards, and regulatory requirements

Lead investigations, root cause analyses, and effectiveness checks for CAPAs and nonconformances

Facilitate CAPA and nonconformance review meetings

Generate and analyze quality metrics and trend data to support management review and continuous improvement

Support preparation for regulatory inspections and notified body audits

Identify and lead opportunities to improve QMS processes, efficiency, and effectiveness

Manage and assess changes to processes, procedures, and products to ensure compliance and risk mitigation

Qualification

ISO 13485FDA QMSR / 21 CFR Part 820Quality Management System (QMS)InternalSupplier auditsCAPA investigationsWritten communicationVerbal communicationCollaborationProblem-solvingOrganizational skills

Required

Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical field

Minimum of 2+ years of experience in a Quality or QMS role, preferably within the medical device industry

Strong working knowledge of ISO 13485

Strong working knowledge of FDA QMSR / 21 CFR Part 820

Strong working knowledge of other applicable international quality standards

Strong written and verbal communication skills

Ability to collaborate effectively across cross-functional teams

Preferred

Experience conducting internal and/or supplier audits

Experience managing nonconformances and CAPA investigations

Company

The Davis Companies

The DAVIS Companies is a preferred source for Staffing Solutions and Talent Advisory Services, specializing in contract, contract-to-hire and direct hire staffing for Engineering, Skilled Manufacturing, IT and Software personnel.

Founded in 1985

Boston, Massachusetts, USA

51-200 employees