Sign upLog in

Quality Engineer 3

Sunrise Systems Inc

Sandy, UT

Apply
JOB DETAILS
SKILLS
Code of Federal Regulations, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation Review, Drug Manufacturing, Equipment Validation, GMP (Good Manufacturing Practices), ICH Regulations, Investigative Reports, Maintain Compliance, Manufacturing, Medical Equipment, Quality Assurance, Quality Engineering, Quality Metrics, Regulations, Risk, Risk Analysis, Risk Management, Technical Writing, Time Management, Writing Skills
LOCATION
Sandy, UT
POSTED
10 days ago
Our client, a leading Medical Device Manufacturing Company is looking for Quality Engineer 3 and This is for an initial duration of 06 MonthsContract – Sandy, UT
 
Job Title: Quality Engineer 3
Job Id: 26-02510
Location: Sandy, UT
Duration: 06 Months Contract
Position Type: Hourly Contract Position (W2 only)

Technical Skills
Must Have 
  • 21 CFR Part 210/211
  • BS in scientific/technical field (or equivalent experience)
  • Direct CAPA authoring
  • Investigation writing
  • Pharmaceutical/Drug Manufacturing
  • Technical Review
Nice To Have 
  • Cleaning Validations
  • Equipment Validation, Transfer, and Qualification
  • ICH Q9
  • OOS Investigations
  • Supplier Assurance
Job Description 
  • Core Hours will be between 8 am-5pm Mon-Fri
  • Temporary (6-month) contract
  • GMP professional to support CAPA deliverables as part of a broader quality remediation initiative, bringing strong knowledge of 21 CFR Part 211 requirements and demonstrated expertise in technical writing and document review within a regulated environment. 
  • The ideal candidate will be capable of independently driving high-quality, inspection-ready outputs while partnering with cross-functional teams and contributing to a risk-based approach to compliance, with additional value placed on familiarity with ICH Q9 principles
Key capabilities include: 
  • Develop and execute CAPA records, ensuring alignment with regulatory expectations and internal quality standards
  • Perform thorough technical writing and critical review of investigations, protocols, and reports
  • Apply 21 CFR Part 211 knowledge to ensure GMP compliance across deliverables and identify potential risks or gaps
  • Collaborate with SMEs and functional teams to drive timely closure of CAPAs and maintain project timelines
  • Additional desired skills in risk assessment and risk management to contribute to or author/review risk assessments using a structured, science- and risk-based approach (ICH Q9 experience preferred)
Qualified candidates please send your word format updated resume at the earliest to Pavan:

Pavan.p@sunrisesys.com

[732-395-4444].
 
Thank You.

About the Company

S

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
http://www.sunrisesys.com/

Resume Resources

Free Resume TemplatesFree Resume Builder