OceansideRecruiter Since 2001
the smart solution for Oceanside jobs

Quality Assurance Manager

Company: Ultimate Staffing
Location: Oceanside
Posted on: April 2, 2021

Job Description:

\n\n ESSENTIAL JOB FUNCTIONS QUALIFICATIONS \n\n 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 in order 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. \n\n \n \n\n \n\n PREFERRED EXPERIENCE \n\n 3-5 years of direct medical device and /or manufacturing experience. 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 \n\n EDUCATION \n\n \n\n------------------High School diploma or some College or equivalent combined work experience and/or school experience.\n\n \n\n \n \n\n \n\n OTHER REQUIREMENTS \n\n 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 \n\n Proficiency office software programs (MS Word, Excel, etc.), Visio a plus.\n\n \n\n \n\n \n\n 1. Responsible for the evaluation and quality reporting of customer complaints, returns and trending of these returns.\n\n \n\n 2. Responsible for gathering all inspection data that supports the monthly and quarterly generation of quality measures and reports.\n\n \n\n 3. Supports the Supply Chain Management processes to assure that the QS is compliant to all regulatory agency requirements.\n\n \n\n 4. Takes a QA support role on all New Product Development teams.\n\n \n\n 5. Oversees the Calibration program.\n\n \n\n 6. Participate in Internal, FDA and ISO audits.\n\n \n\n 7. Assigned as required to support Customer driven projects \n\n As the person responsible for regulatory compliance (PRRC Representative), the QA Manager shall at least be responsible for ensuring that: \n\n (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;\n\n \n\n (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;\n\n \n\n (c) the post-market surveillance obligations are complied with in accordance with MDR (EU) 2017/745, Article 10(10);\n\n \n\n (d) the reporting obligations referred to in MDR (EU) 2017/745, Articles 87 to 91 are fulfilled;\n\n \n\n (e) in the case of investigational devices, the statement referred to in MDR (EU) 2017/745, Section 4.1 of Chapter II of Annex XV is issued\n\n

Keywords: Ultimate Staffing, Oceanside , Quality Assurance Manager, Executive , Oceanside, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Assistant General Manager
Description: Start Your New Career Today enjoy job stability with Jiffy Lube as an Essential Business IMMEDIATELY HIRING --Safety is our priority COVID-19 protocols are in place --Team Car Care owns and operates (more...)
Company: Jiffy Lube
Location: Carlsbad
Posted on: 04/14/2021

ServiceMax Project Manager (REMOTE)
Description: Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research Pharmaceutical industry, seeks an accomplished ServiceMax Project (more...)
Company: Amerit Consulting
Location: San Diego
Posted on: 04/14/2021

Director Case Management and Social Work
Description: Director Case Management Social Work - Sharp Memorial Hospital-Summary:-The Director Case Management Social Work is accountable for coordinating the ongoing development and productivity of designated (more...)
Location: San Diego
Posted on: 04/14/2021

SVP, Chief Information Officer
Description: USE Credit UnionJob ID 2Job Locations US-CA-San DiegoCategory Information TechnologyType Regular Full-TimeMore information about this jobOverview br Are you Service-Driven and Innovative USE's Information (more...)
Company: USE Credit Union
Location: San Diego
Posted on: 04/14/2021

Maintenance Manager
Description: Maintenance Manager with experience around fermentation needed NOW br br This Jobot Job is hosted by JR Denning br Are you a fit Easy Apply now by clicking the Apply button and sending us your (more...)
Company: Jobot
Location: San Diego
Posted on: 04/14/2021

Salon Manager - Santee Village Square
Description: Salon Manager Got shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: La Jolla
Posted on: 04/14/2021

Restaurant Manager
Description: Puesto - Join the FamiliaWHY US At Puesto we are uncommonly positive, we work hard to consistently exceed expectations and provide you with the opportunity to grow and learn. We are natural hosts, entertainers (more...)
Company: Puesto
Location: San Diego
Posted on: 04/14/2021

Business Management Manager 1
Description: Category: Business ManagementLocation: San Diego, CaliforniaUS Citizenship Required for this Position: YesClearance Type: NoneTelecommute: No -Teleworking not available for this positionShift: 1st ShiftTravel (more...)
Company: Northrop Grumman
Location: San Diego
Posted on: 04/14/2021

Director of Operations-West Coast
Description: Visionary Leader. Strategic Thinker. Join Staff Management - SMX as our next Director of Operations. As a Director of Operations, the continued success of our relationship with our partners depends on (more...)
Company: Staff Management
Location: San Diego
Posted on: 04/14/2021

Director Of Quality Assurance
Description: Open to Director or Associate Director based on experience br HIGHLIGHTS ul li Lead and build the foundation for the QA division from pre-clinical through clinical studies li Be on the cutting (more...)
Company: SQRL
Location: San Diego
Posted on: 04/14/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Oceanside RSS job feeds