Quality Engineer

Quality Engineer for medical device manufacturing to lead NCMR/CAPA, process validation, and data-driven improvements in electro/electro-mechanical production.

Requirements

• BS in Engineering and 3+ years in medical device manufacturing or quality

• Hands-on NCMR ownership (intake, disposition, containment)

• CAPA leadership (problem definition, root cause, corrective/preventive action, effectiveness checks)

• Process validation experience (IQ/OQ/PQ; protocol/report authoring)

• DMAIC methodology and process mapping (current/future state, CTQs, control plans)

• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and EU MDR

• SAP or comparable ERP usage for quality records, routings, and BOM traceability

• Experience in cleanroom or similarly controlled production environments

• Familiarity with electro/electro-mechanical assemblies and test methods

Preferred Skills

• Risk management per ISO 14971 (FMEA, fault tree)

• Statistical tools (MSA, Gage R&R, capability studies) using Minitab or equivalent

• Supplier quality involvement (SCARs, incoming inspection plans, PPAP/APQP exposure)

• Electronic DHR/eQMS workflows and document control systems

• Data visualization and reporting in Excel (pivot tables, lookups) or BI tools

Responsibilities

• Lead NCMR triage, investigation, and disposition; track trends and drive systemic fixes

• Manage CAPA lifecycle from initiation through verification of effectiveness

• Plan and execute process validations (IQ/OQ/PQ), including test method validation and sampling rationale

• Map processes, identify waste/variation, and implement controls (SPC, control plans, standard work)

• Maintain compliant documentation within eQMS/Document Control and ERP (SAP)

• Coordinate change control and verification/validation impacts for product and process changes

• Collaborate with manufacturing and test engineering on defect reduction, yield improvement, and line readiness

• Prepare quality metrics and reports for audits, management review, and regulatory inspections

Pay Details: $30.00 to $42.00 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.