The Griffin Groupe
Overview
Quality Assurance Manager – The Griffin Groupe is searching for talented quality professionals to join our client in the medical device manufacturing industry.
Job Type: Full Time • Location: Oceanside, CA • Industry: Medical Equipment • Rate: $120-140K + Bonus + Benefits
Responsibilities and requirements reflect the role of implementing and maintaining the Business (Quality) Management System and overseeing the Quality Department, including document control, corrective and preventive action, and design and development support to ensure compliance with ISO 13485 and regulatory requirements. This position also acts as the PRRC (Person Responsible for Regulatory Compliance) Representative and reports directly to the President.
Responsibilities
Provide BMS support, including the management of the Quality Assurance department, personnel, and all stages of inspection: receiving, in-process, finished goods, and returned goods.
Oversee raw material and supplier quality, Document Control, corrective and preventive action, and design and development support to maintain and enhance ISO 13485 compliance.
Key Auditor Trainer – provide in-house training and refresher training for the Internal Auditing group.
Facilitate the corrective and preventive action program and assist responsible parties to close CAPA actions; conduct verification audits to ensure CAPA effectiveness.
Facilitate Management Review after internal audits and CAPA initiation; develop the agenda, correlate data for presentation to Top Management, and initiate corrective and preventive actions from the review.
Required Education & Qualifications
High School diploma or some college or equivalent combined work experience and/or school experience.
3-5 years of direct medical device and/or manufacturing experience. Experience with receiving inspection plan development.
Experience with sterile disposable products is a plus.
Knowledge of FDA/QSR Quality System, ISO 13485 requirements and Medical Device Directives.
Works well in a fast-paced, team environment.
Excellent written and verbal communication skills.
Quick learner and capable of achieving goals with limited supervision.
Resourceful, self-motivated.
Good interpersonal skills, experienced in conflict resolution.
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Job Type: Full Time • Location: Oceanside, CA • Industry: Medical Equipment • Rate: $120-140K + Bonus + Benefits
Responsibilities and requirements reflect the role of implementing and maintaining the Business (Quality) Management System and overseeing the Quality Department, including document control, corrective and preventive action, and design and development support to ensure compliance with ISO 13485 and regulatory requirements. This position also acts as the PRRC (Person Responsible for Regulatory Compliance) Representative and reports directly to the President.
Responsibilities
Provide BMS support, including the management of the Quality Assurance department, personnel, and all stages of inspection: receiving, in-process, finished goods, and returned goods.
Oversee raw material and supplier quality, Document Control, corrective and preventive action, and design and development support to maintain and enhance ISO 13485 compliance.
Key Auditor Trainer – provide in-house training and refresher training for the Internal Auditing group.
Facilitate the corrective and preventive action program and assist responsible parties to close CAPA actions; conduct verification audits to ensure CAPA effectiveness.
Facilitate Management Review after internal audits and CAPA initiation; develop the agenda, correlate data for presentation to Top Management, and initiate corrective and preventive actions from the review.
Required Education & Qualifications
High School diploma or some college or equivalent combined work experience and/or school experience.
3-5 years of direct medical device and/or manufacturing experience. Experience with receiving inspection plan development.
Experience with sterile disposable products is a plus.
Knowledge of FDA/QSR Quality System, ISO 13485 requirements and Medical Device Directives.
Works well in a fast-paced, team environment.
Excellent written and verbal communication skills.
Quick learner and capable of achieving goals with limited supervision.
Resourceful, self-motivated.
Good interpersonal skills, experienced in conflict resolution.
#J-18808-Ljbffr