Quality Assurance Manager in Riverside, CA at GPAC

Date Posted: 6/16/2022

Job Snapshot

Job Description

POSITION SUMMARY

Responsible for implementation and enhancement of the Business (Quality) Management System and overseeing the Quality Department. Responsible for Document Control, corrective and preventive action, and design and development support to maintain and enhance compliance with ISO 13485, and regulatory requirements including acting as the PRRC (Person Responsible for Regulatory Compliance) Representative. This position reports directly to the President.

ESSENTIAL JOB FUNCTIONS

Provide BMS support, including the management of the Quality Assurance department. This includes the management of personnel and their activities, overseeing all stages of inspection: receiving, in­ process, finished goods, returned goods.

Oversee raw material and supplier quality, Document Control, corrective and preventive action, and design and development support to maintain and enhance compliance with ISO 13485 requirements.

Key Auditor Trainer - provide in-house training and refresher training for the Internal Auditing group.

Facilitate the corrective and preventive action program and assist the responsible parties as to the activities required to close the CAPA actions. Will also conduct verification audits to ensure that previous CAPA taken is closed and effective.

Facilitate Management Review following completion of the internal audit and initiation of corrective and preventive action activities, develop the agenda, help correlated the data for presentation to Top Management, and initiate any corrective and preventive actions resulting from Management Review.


  • Responsible for the evaluation and quality reporting of customer complaints, returns and trending of these


  • Responsible for gathering all inspection data that supports the monthly and quarterly generation of quality measures and


  • Supports the Supply Chain Management processes to assure that the QS is compliant to all regulatory agency


  • Takes a QA support role on all New Product Development


  • Oversees the Calibration


  • Participate in Internal, FDA and ISO


  • Assigned as required to support Customer driven Project here.

  • QUALIFICATIONS

    Education: High School diploma or some College or equivalent combined work experience and/or school experience.

    Experience/Preferred:

    • 3-5 years of direct medical device and /or manufacturing Experience with receiving inspection plan development.
    • Experience with sterile disposable products a plus
    • Knowledgeable of FDA/QSR Quality System, ISO 13485 requirements and Medical Device Directives

    Specific Skills/Knowledge:

    • Works well in a fast paced, team environment
    • Must have excellent communication skills (written & verbal)
    • A quick learner and capable of being successful in achieving goals with limited

    supervision

    • Resourceful, self-
    • Good interpersonal skills, experienced in conflict

    Resolution.

    OTHER REQUIREMENTS --

    Physical - Will be required to move raw materials and

    equipment with assistance

    Inspection tools - Must have working knowledge of the use of basic Calipers, scales/rulers, Micrometers. Must be able to read product specifications/drawings.

    Computer Skills -Proficiency office software programs (MS Word, Excel, etc.}, Visio a plus.

    For additional information on this opportunity, please contact Daniel Gonzalez directly at 605.799.8637 Resumes may be confidentially sent to daniel.gonzalez@gogpac.com

    All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

    GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

    Job Requirements

    POSITION SUMMARY

    Responsible for implementation and enhancement of the Business (Quality) Management System and overseeing the Quality Department. Responsible for Document Control, corrective and preventive action, and design and development support to maintain and enhance compliance with ISO 13485, and regulatory requirements including acting as the PRRC (Person Responsible for Regulatory Compliance) Representative. This position reports directly to the President.



    ESSENTIAL JOB FUNCTIONS

    Provide BMS support, including the management of the Quality Assurance department. This includes the management of personnel and their activities, overseeing all stages of inspection: receiving, in­ process, finished goods, returned goods.



    Oversee raw material and supplier quality, Document Control, corrective and preventive action, and design and development support to maintain and enhance compliance with ISO 13485 requirements.



    Key Auditor Trainer - provide in-house training and refresher training for the Internal Auditing group.



    Facilitate the corrective and preventive action program and assist the responsible parties as to the activities required to close the CAPA actions. Will also conduct verification audits to ensure that previous CAPA taken is closed and effective.



    Facilitate Management Review following completion of the internal audit and initiation of corrective and preventive action activities, develop the agenda, help correlated the data for presentation to Top Management, and initiate any corrective and preventive actions resulting from Management Review.

    Responsible for the evaluation and quality reporting of customer complaints, returns and trending of these


    Responsible for gathering all inspection data that supports the monthly and quarterly generation of quality measures and


    Supports the Supply Chain Management processes to assure that the QS is compliant to all regulatory agency


    Takes a QA support role on all New Product Development


    Oversees the Calibration


    Participate in Internal, FDA and ISO


    Assigned as required to support Customer driven Project here.


    QUALIFICATIONS

    Education: High School diploma or some College or equivalent combined work experience and/or school experience.

    Experience/Preferred:

    3-5 years of direct medical device and /or manufacturing Experience with receiving inspection plan development.
    Experience with sterile disposable products a plus
    Knowledgeable of FDA/QSR Quality System, ISO 13485 requirements and Medical Device Directives
    Specific Skills/Knowledge:

    Works well in a fast paced, team environment
    Must have excellent communication skills (written & verbal)
    A quick learner and capable of being successful in achieving goals with limited
    supervision

    Resourceful, self-
    Good interpersonal skills, experienced in conflict
    Resolution.



    OTHER REQUIREMENTS --

    Physical - Will be required to move raw materials and

    equipment with assistance



    Inspection tools - Must have working knowledge of the use of basic Calipers, scales/rulers, Micrometers. Must be able to read product specifications/drawings.



    Computer Skills -Proficiency office software programs (MS Word, Excel, etc.}, Visio a plus.

    For additional information on this opportunity, please contact Daniel Gonzalez directly at 605.799.8637 Resumes may be confidentially sent to daniel.gonzalez@gogpac.com