MillenniumSoft Inc
Senior Staff Quality Engineer (Strong Medical Device Exp) Onsite
MillenniumSoft Inc, San Diego, California, United States, 92189
Senior Staff Quality Engineer (Strong Medical Device Exp) Onsite
Position :
Senior Staff Quality Engineer (Strong Medical Device Exp) Location : San Diego, CA Duration : 12 Months Total Hours/week : 40.00 1st Shift Client : Medical Devices 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) Job Description
The Sr. Staff Quality Engineer is a contract role that will be responsible for leading a project to improve the Quality and compliance of the Dispensing Implementation process. This role will work with the Dispensing Implementation teams to document and suggest compliance-related improvements or changes to that process. The intent of this role is to bring the Dispensing Implementation process to a state of compliance that would pass an external regulatory agency inspection. Duties Include
Evaluating the Dispensing Implementation process against regulatory requirements associated with CFR 820.200 and international regulatory requirements. Leading a cross-functional effort to develop and execute the plan to improve the compliance state of the process. Communicate weekly status to the Quality and SDS leadership teams. Compliance to all service record documentation requirements. Adherence to BD Inspire Quality Processes Driving effective and efficient installation and implementation execution. Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services. What is expected of you for success in your role
Demonstrates strong knowledge of quality engineering policies, principles and best practices Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision Represents Quality organization on project Core Team(s) Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…) Acts as a resource for colleagues with less experience Collaborates across functions and TGS to drive effective and confident compliance. Qualifications
Qualified candidates will have a Bachelor’s degree in a relevant degree field (engineering) and minimum 10 years’ experience in a Quality role in FDA regulated environments. Demonstrated experience with the Quality requirements for installation of medical devices is required. Extensive demonstrated history completing quality/compliance improvement projects in an FDA regulated environment is required. Demonstrated experience with installation of medical devices with embedded software is strongly preferred. Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and be efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Proficiency in Excel, Word, and other desktop/general business systems Quality Engineering Certification (ASQ) or equivalent (preferred) Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Staffing and Recruiting
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Position :
Senior Staff Quality Engineer (Strong Medical Device Exp) Location : San Diego, CA Duration : 12 Months Total Hours/week : 40.00 1st Shift Client : Medical Devices 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) Job Description
The Sr. Staff Quality Engineer is a contract role that will be responsible for leading a project to improve the Quality and compliance of the Dispensing Implementation process. This role will work with the Dispensing Implementation teams to document and suggest compliance-related improvements or changes to that process. The intent of this role is to bring the Dispensing Implementation process to a state of compliance that would pass an external regulatory agency inspection. Duties Include
Evaluating the Dispensing Implementation process against regulatory requirements associated with CFR 820.200 and international regulatory requirements. Leading a cross-functional effort to develop and execute the plan to improve the compliance state of the process. Communicate weekly status to the Quality and SDS leadership teams. Compliance to all service record documentation requirements. Adherence to BD Inspire Quality Processes Driving effective and efficient installation and implementation execution. Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services. What is expected of you for success in your role
Demonstrates strong knowledge of quality engineering policies, principles and best practices Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision Represents Quality organization on project Core Team(s) Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…) Acts as a resource for colleagues with less experience Collaborates across functions and TGS to drive effective and confident compliance. Qualifications
Qualified candidates will have a Bachelor’s degree in a relevant degree field (engineering) and minimum 10 years’ experience in a Quality role in FDA regulated environments. Demonstrated experience with the Quality requirements for installation of medical devices is required. Extensive demonstrated history completing quality/compliance improvement projects in an FDA regulated environment is required. Demonstrated experience with installation of medical devices with embedded software is strongly preferred. Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and be efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Proficiency in Excel, Word, and other desktop/general business systems Quality Engineering Certification (ASQ) or equivalent (preferred) Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Staffing and Recruiting
#J-18808-Ljbffr