Summary: Seeking a Quality Engineer to oversee and improve manufacturing processes in the medical device industry, ensuring compliance with regulatory requirements and driving continuous improvement initiatives.

Requirements:

Bachelor's degree in engineering, science, or equivalent Minimum of 3 years experience in the medical device industry Knowledge of ISO13485 standards and Quality Management Systems Experience in quality assurance, quality engineering, or related functions

Preferred Skills:

CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor)

Responsibilities:

Oversee and enhance product quality and customer satisfaction Establish and maintain Quality Management System (QMS) Lead efforts to sustain and enhance quality compliance Revise quality processes/procedures for QMS effectiveness Coordinate quality improvement efforts across departments Review design plans, process procedures, test procedures Ensure products meet quality and integrity requirements Provide analysis throughout inspection process Identify root causes of production problems; implement corrective measures Analyze data for trends in product quality or defects Investigate nonconformities; handle deviation approvals and complaints Assist in revising/creating procedures and maintaining Risk Management Plans/Files Maintain document control system; handle Change orders Assist in regulatory audits and CAPA initiation/closure

Pay Details: $120,000.00 to $135,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.