Basic Information

Job Category: Engineering

Location: Huntington, California, United States

Date published: 04-May-2022

Job type: Full Time

Description and Requirements

About the role

Validation/Quality Engineer

An ADP Client is currently seeking a Validation/Quality Engineer to join our team in Huntington Beach, CA 92649.

About the role:

The Validation Quality Engineer is responsible for the validation and revalidation of machines, equipment and process based on defined protocols. Will support activities to maintain and improve the quality management system and ensure compliance to ISO, regulatory and customer requirements.

Who We Are:

SteriPax - Flexible Packaging for the Medical Device Industry.    SteriPax was founded in 1994 on the west coast to fill a need for a service oriented medical packaging company. Our commitment was and still is, to provide the highest quality products faster and more reliable than what the industry is accustomed to.

To accomplish these goals, we maintain raw materials inventories to minimize the bottleneck of fluctuating lead times. Combining this with stocking programs established with our clients and we reduce inventories and cost. This is a win win situation for us and our clients.

What you’ll do:

Quality Related Requirements:

Create, review and/or update procedures and work instructions.

Create, review and/or update product specifications.

Create, review and/or revise quality policies and procedures and systems to help ensure compliance to ISO, regulatory and customer requirements.

Support supplier control activities including leading or supporting supplier audits, assessments and/or conducting supplier surveys.

Works with department managers to train personnel on processes and quality procedures.

Lead and/or participate in change control activities throughout the manufacturing and operations processes.

Support internal audit process to ensure compliance to ISO standard requirements.

Perform root cause analysis, preventative, and corrective actions to eliminate non-conformances.

Support site production and engineering functions in process quality improvement activities.

Compile and analyze manufacturing and quality metrics, analyze trends and report to quality management.

Maintain and/or support the maintenance of the approved supplier list, equipment calibration and internal audit process.

Support or manage the NCR / MRB process

Develop, create, implement, maintain, or modify gauge R&R protocols for test equipment and personnel.

May lead, support, or follow up on customer complaint investigations.

Perform other duties as assigned.

Validation Related Requirements:

Conduct IQ, OQ and PQ trails for machine/process validations or revalidations.

Evaluate validation results and create validation test reports.

Develop, update, implement or modify machine and/or process validation protocols and manufacturing ranges for material combinations.

Evaluate and validate new materials and/or material combinations.

Create, review, or update machine and process validation procedures.

Our Perfect Candidate:

Education and Experience

Bachelor’s degree in engineering, science, technology, or another related field is preferred, but not required.

Experience and/or knowledge with ISO standards 13485, 9001 or 11607 and/or FDA 21 CFR 820 requirements is preferred, but not required.

2+ years of manufacturing quality or validation experience is preferred but not required.

Education and/or experience with machine and/or process validations (IQ, OQ and PQ) is strongly preferred, but not required.

Basic computer skills including proficiency in applications such as MS Outlook, Word, PowerPoint, and Visio; advanced proficiency in Excel is preferred.

Ability to communicate with all levels of personnel from production level operators to upper management and customers or suppliers.

Education and/or experience with medical device manufacturing, medical device packaging, pharmaceutical or other regulated industry is preferred, but not required.

Education and/or experience high-volume manufacturing is preferred, but not required.

Education and/or experience with FDA requirements for medical devices and/or cGMP practices is preferred, but not required.

Abilities and Skills:

Ability to speak, read and write fluently in English is strongly desired.

Ability to speak, read and write in Vietnamese is a plus.

Excellent critical thinking and analysis skills is desired.

Education and/or experience with complaint investigations, risk assessments, root cause analysis, CAPA, Investigations, NCMR, Engineering, FDA, quality engineering, quality assurance, remediation, risk management is preferred, but not required.

Education and/or experience with statistical process control, statistical quality control or design of experiments is preferred, but not required.

What we offer:

Competitive salary will be commensurate with experience and education.

Comprehensive benefits package available: (healthcare, vision, dental and life insurances; 401k plan; paid vacation, sick days, and holidays).

To Apply:

Please submit your resume via the ‘Apply Now’ button!

We are an Equal Opportunity Employer!

Keywords:  CAPA, NCMR, FDA, cGMP, medical devices, root cause analysis, machine and/or process validations (IQ, OQ and PQ), ISO standards 13485, 9001 or 11607 and/or FDA 21 CFR 820, machine/process validations or revalidations, NCR / MRB process