Quality Specialist

Perform quality inspections, documentation review, and quality system activities within a regulated medical device or manufacturing environment.

Job Requirements

• High school diploma or GED.

• Minimum of 3 years of experience in a quality role within a medical device company or equivalent technical experience in a regulated manufacturing environment.

• Experience with Quality Management Systems such as ISO 9001, ISO 13485, or other regulated industry standards.

• Experience using hand inspection equipment including calipers, micrometers, plug gauges, and thread gauges.

• Experience using and programming Keyence Vision Systems.

• Experience using electronic Quality Management Systems.

• Experience using ERP systems.

• Knowledge of quality concepts including QMS, line clearance, CAPA, audits, and Good Documentation Practices.

• Experience reading engineering drawings and schematics.

• Experience performing quality work in a medical device or other regulated industry.

Preferred Skills

• Bachelor’s degree.

• Professional quality certification such as CQE, CRE, Six Sigma, or related certification.

• Advanced degree in a quality-related discipline.

• Experience with document control systems.

• Experience managing training records.

• Experience supporting internal and external audits.

• Experience with Device History Records and Device Master Records.

• Experience with Supplier Corrective Action Requests.

Job Responsibilities

• Perform quality control inspections of medical devices in accordance with procedures and SOPs.

• Perform incoming and final inspections of components.

• Inspect components against approved fabrication drawings and material inspection plans.

• Complete inspection and nonconformance documentation.

• Review Device History Records for completeness and accuracy.

• Maintain document control records as required.

• Coordinate and maintain training records as required.

• Maintain technical documentation and Device Master Record files.

• Support change control documentation activities.

• Assist with internal and external audit preparation and record retrieval.

• Support Supplier Corrective Action Requests.

• Support CAPA activities.

• Maintain quality and inspection records in applicable electronic systems.

Pay: 22-30/hr

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $22.00 to $30.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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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 Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San 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.