Job Description

Job Title: Quality Engineer Medical Devices

Job Id: 24-05182

Location: San Diego, CA

Duration: 12 Months Contract[W2]

Position Type: Hourly Contract Position (W2 only)

• 100% onsite 5 days a week

Job Summary Validation QE II and SR QE(Validation) :

• As directed by the Quality Engineering Leader, the Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies.

• Successful performance requires close work with quality management, operations, suppliers and/or Client associates to assure compliance with all Client quality policies, procedures, and practices.

• Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I/II/II products. Preferred core experience in Quality Assurance, Quality Control, Validation (IQ,OQ,PQ) and Nonconformance management for regulated devices(i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities.

• Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners.

• Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment.

• Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility.

• Review and update FMEA or Risk documents as needed for validation activity for the site

• Perform additional duties to ensure business continuity during the relocation of the manufacturing processes into new area. Duties include but not limited to execution of QA inspection to support dual operations, review and approval of documents such as batch records to support finished product release.

Education and Experience:

• BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field

• Minimum of 3-5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device, Biotech or Pharma Industry.

Knowledge and Skills:

• Strong verbal and written communication skills; ability to write technical documents. Knowledge of

• quality system methodologies

• Statistical Analysis basic knowledge e.g Minitab or Excel

• Strong knowledge of Process Validation and equipment validation

• Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management)

• Hands on experience using Six Sigma methodology

• SAP knowledge

• Equipment management system such as BMRAM knowledge preferred

• The ability to work in teams and independently with minimal supervision to obtain results as required.

• Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.

Physical Demands: (if applicable)

• General physical requirements: ability to work in controlled environmental

• Ability to work with laboratory grade equipment such as refrigerators, freezers, centrifuges, etc during validation work.

Qualified candidates please send your word format updated resume at the earliest to:

• Pavan: Pavan.p@sunrisesys.com [732-272-0382]
• Sangeeth: Sangeeth.k@sunrisesys.com [732-272-0281]

Thank you,

Sunrise Systems Inc.

About the Company:
Sunrise Systems Inc

Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.

We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.

Our collective business experience spans over two and a half decades and ranges from:

• Business, management, and technical fields
• Information technology consulting and software solutions.
• Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
• Motivating technology staff and establishing partnerships with Fortune 500 companies

Sunrise Systems has a vast range of competence in:

• Design, development, and support of cloud-based solutions from simple to highly complexed
• Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
• Data processing and data migration
• Application re-engineering and platform migration
• Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.

Company Size:
100 to 499 employees

Industry:
Staffing/Employment Agencies

Founded:
1990

Website:

Job Tags

Hourly pay, Contract work, Relocation, Flexible hours,

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