MillenniumSoft Inc
Engr 2, Quality (Must Have Risk Management, Design Control & Chan...
MillenniumSoft Inc - San Diego, California, United States, 92189
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Overview
Engr 2, Quality (Must Have Risk Management, Design Control & Change Control Exp)
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Engr 2, Quality (Must Have Risk Management, Design Control & Change Control Exp)
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11 months ago Be among the first 25 applicants Join to apply for the
Engr 2, Quality (Must Have Risk Management, Design Control & Change Control Exp)
role at
MillenniumSoft Inc Position : Engr 2, Quality (Must Have Risk Management, Design Control & Change Control Exp)
Location : San Diego, CA
Duration : 9 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Engineering
Level of Experience: Senior Level
Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
3 Must Haves On The Resume:
Risk Management Knowledge, Design controls exposure, Knowledge with Engineering change control processes, targeted knowledge with MDR
Responsibilities:
Job Description:
Support modification and maintenance of quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements Implement Corporate and Business level Quality System procedures for the design center locations under supervision Facilitate internal quality system audits per the procedural requirements Support the management of external audits Lead or Support the development of content for the management review process Update and report on monthly quality metrics Provide inputs on revisions to Corporate and Business level procedures as necessary Support supplier management efforts for the design center Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements
Scope Of Responsibilities:
Work is performed without appreciable direction Determine and pursue course of action necessary to obtain desired results
Educational Requirements:
A minimum of Bachelor’s degree in Science or related discipline Certified ISO 9001/13485 Lead auditor is desirable Knowledge of Design Control, Risk Management and QMS processes Minimum 1-2 years of experience developing and sustaining quality systems of medical devices
Knowledge And Skills:
Exposed to internal and external audits as an auditor and/ or auditee Some knowledge of applicable regulatory and industry standards (21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, etc.) Good technical writing, communication skills, and managing small quality system project Desirable knowledge with Design Control/ Change control process, CAPA, Deviations and Non-conformances Design Control EU MOD/MOR Change control Risk Management Process Validation Identification of CTQ's Handling of deviations and non-conformances Test method validations CAPA- Root cause investigation and implementation of corrective / preventive actions Proper Use of Statistics (Sampling Plans) Advise on Regulations and standards Liaise with Manufacturing Plants Provide functional support to cross-functional teams G Support Internal and external audits
Requirements:
Bachelor's Degree A minimum of 9 years of relevant experience or a combination of equivalent education and relevant experience Minimum 2 - 3 years of experience supporting design assurance for medical devices Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements. Applicable Regulatory and Industry standards (21-CFR-820, ISO '13485, MOD, MOR, ISO 14971,ISO 10993, etc.)
Knowledge And Skills:
Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication ASQ Certificate(s) desirable (but not required)
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Staffing and Recruiting Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x Get notified about new Quality Engineer jobs in
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Join to apply for the
Engr 2, Quality (Must Have Risk Management, Design Control & Change Control Exp)
role at
MillenniumSoft Inc Continue with Google Continue with Google Engr 2, Quality (Must Have Risk Management, Design Control & Change Control Exp)
11 months ago Be among the first 25 applicants Join to apply for the
Engr 2, Quality (Must Have Risk Management, Design Control & Change Control Exp)
role at
MillenniumSoft Inc Position : Engr 2, Quality (Must Have Risk Management, Design Control & Change Control Exp)
Location : San Diego, CA
Duration : 9 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Engineering
Level of Experience: Senior Level
Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
3 Must Haves On The Resume:
Risk Management Knowledge, Design controls exposure, Knowledge with Engineering change control processes, targeted knowledge with MDR
Responsibilities:
Job Description:
Support modification and maintenance of quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements Implement Corporate and Business level Quality System procedures for the design center locations under supervision Facilitate internal quality system audits per the procedural requirements Support the management of external audits Lead or Support the development of content for the management review process Update and report on monthly quality metrics Provide inputs on revisions to Corporate and Business level procedures as necessary Support supplier management efforts for the design center Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements
Scope Of Responsibilities:
Work is performed without appreciable direction Determine and pursue course of action necessary to obtain desired results
Educational Requirements:
A minimum of Bachelor’s degree in Science or related discipline Certified ISO 9001/13485 Lead auditor is desirable Knowledge of Design Control, Risk Management and QMS processes Minimum 1-2 years of experience developing and sustaining quality systems of medical devices
Knowledge And Skills:
Exposed to internal and external audits as an auditor and/ or auditee Some knowledge of applicable regulatory and industry standards (21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, etc.) Good technical writing, communication skills, and managing small quality system project Desirable knowledge with Design Control/ Change control process, CAPA, Deviations and Non-conformances Design Control EU MOD/MOR Change control Risk Management Process Validation Identification of CTQ's Handling of deviations and non-conformances Test method validations CAPA- Root cause investigation and implementation of corrective / preventive actions Proper Use of Statistics (Sampling Plans) Advise on Regulations and standards Liaise with Manufacturing Plants Provide functional support to cross-functional teams G Support Internal and external audits
Requirements:
Bachelor's Degree A minimum of 9 years of relevant experience or a combination of equivalent education and relevant experience Minimum 2 - 3 years of experience supporting design assurance for medical devices Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements. Applicable Regulatory and Industry standards (21-CFR-820, ISO '13485, MOD, MOR, ISO 14971,ISO 10993, etc.)
Knowledge And Skills:
Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication ASQ Certificate(s) desirable (but not required)
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Staffing and Recruiting Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x Get notified about new Quality Engineer jobs in
San Diego, CA . Electrical Engineer Avionics and Electrical Systems
Electrical Engineer Avionics and Electrical Systems
San Diego, CA $71,300.00 - $117,300.00 6 hours ago Poway, CA $105,000.00 - $125,000.00 4 months ago Poway, CA $120,000.00 - $140,000.00 1 month ago Hardware Engineer/ Reliability Engineer(CAD, IEEE or IEC or FDA Required) - Remote
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr