Product Quality Hardware Engineer

Job Title:               Product Quality Hardware Engineer

Location:               Mountain View, California, US

Job Type:               Contract

Duration:               6 Months 

About Our Client: Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives

Job Description:

• Product Quality Hardware Engineer, Devices and Services
• Travel: Expected Travel is up to 20%

Qualifications:

Minimum Qualifications:

• Bachelor's degree in Engineering or Science Related Field
• 5 years of experience in Medical Device Manufacturing
• Understanding of US and International Medical Device Regulations with experience interacting with Regulatory Agencies (FDA, Notified Bodies, Etc)
• Experience participating in regulatory and quality audits and presenting technical subjects to regulators.
• Experience in Program Management, Training and working with hardware development teams.
• Experience with Medical Device Product Development Lifecycle
• Familiarity with ISO13485 and 21 CFR Part 820 and Quality Management Systems (QMS)
• Excellent organizational, independent productivity, and verbal and written communication skills.
• Ability to travel internationally up to 20%

Preferred Qualifications:

• Masters Degree in Engineering or Science Related Field
• Certified Quality Engineer (ASQ) or Six Sigma Green/Blackbelt
• Experience with both Consumer and Regulated Products
• Experience working with novel technologies in an ambiguous and innovative environment.
• Experience with Risk Management, Design/Process Verification and Validation
• Strong knowledge of Quality Concepts (Statistical Analysis, NC/CAPA, Audits)
• Experience with Good Documentation Practices and Good Manufacturing Practices
• Applied knowledge of Quality tools such as Failure Modes Effect Analysis (xFMEA), Root Cause Analysis, and Mistake Proofing/Poke Yoke

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities

Reach Out To A Recruiter

Recruiter:             Sherman Elle

Email:                   Shermane@askstaffing.com

Phone:                  678-250-9916/: 678-890-5130