Top 1 Qa process engineer Jobs in Santa Maria, Ca

QA Process Engineer
Hardy Diagnostics —Santa Maria, CA
- Urgently hiring
- Bachelor of Science
- Mid-level
- 2 years
- Profit sharing
- Employee stock ownership plan
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QA Process Engineer

Hardy Diagnostics -
Santa Maria, CA

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Job Details

Full-time

Benefits

Profit sharing
Employee stock ownership plan

Qualifications

Customer complaint resolution

Full Job Description

Hardy Diagnostics a 100% employee owned company and is now hiring!

We are looking for another dedicated person to join us. We have an immediate opening for a full time QA Process Engineer. If you have a passion for excellence and would like to join a stable and growing company then we'd like to talk to you.

The QA Process Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the QA Process Engineer will apply diversified knowledge of engineering, quality principles and practices for medical devices and laboratory use only products.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may

be assigned.

Maintains and improves the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
Supports quality assurance activities, including, but not limited to: Risk Management, internal and external audits, NCMRs and CAPAs
Investigates product quality problems (NCs and deviations) and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
Manages the Control of Non-conforming Products (CNP) in collaboration with the applicable stakeholders, to ensure timely reporting, analysis, and resolution of non-conforming material
Leads/supports the resolution of quality issues related to non-conformance reports, deviations, customer complaints and CAPAs
Oversee the deviation process for the review and approval of manufacturing deviations
Supports manufacturing team in the maintenance and continuous improvement of product and manufacturing processes
Leads and administrates the CNP and CRB meeting
Serves as subject matter expert for root cause analysis
Provides QE support to production, purchasing and engineering
Supports/leads test method validation activities and/or other validation activities as needed
Develops and initiates sampling procedures and statistical process control methods
Other duties/ activities may be necessary to support departmental or company goal

EDUCATION and/or EXPERIENCE

Bachelor’s degree (B.S./B.A.) in engineering or related discipline
Minimum three (3) years of experience working in a regulated industry
Minimum two (2) years of experience in quality in a regulated industry

We also help make our employees better by offering a wide range of educational and training opportunities as well as a full line of benefits, including profit-sharing. Our employees eventually become owners through our Employee Stock Ownership Program (ESOP). The dedication and skill of the people who work here have resulted in remarkable success-Inc. Magazine has recognized us as one of the Fastest Growing Private Companies in America. In addition, we are a “Fit Friendly” business as certified by the American Heart Association and a “Green Business” as certified by the County of Santa Barbara.

Hardy Diagnostics is an Equal Opportunity Employer: Minorities / Females / Veterans / Disability

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

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QA Process Engineer

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