Job Title - Sr. Quality Engineer II
Location -Irvine, CA, 92614
Duration: 6 Months +

This Sr. Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory.
 
How you will make an impact:

• Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs
• Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Coordinate and execute change control activities to support rapid innovation
• Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.)
• Participate in escalation tasks and activities, including Project Risk Assessments (PRA)
• Supports or leads test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs
• Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching of robust products
• Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Assign and oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Other incidental duties assigned by Leadership
• Ability to travel up to 10% domestically and internationally

 What you’ll need (Required Qualifications):

• Bachelor’s degree in engineering with a minimum of (4) years of experience in either NPD, Quality Engineering, R&D, and/or Manufacturing; OR a master’s degree in engineering or Scientific field with internship, senior projects, or thesis experience required.
• Engineering experience within a highly regulated industry

 
What else we look for (Preferred Qualifications):

• Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
• Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
• Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
• New Product Development experience from initial concept to commercialization (Class III preferred).
• Experience with Risk Management and Design Control
• Proven expertise in usage of MS Office Suite including MS Excel, Power Point, and WordProject
• Experience with using Adobe Acrobat
• Basic understanding of statistical techniques
• Strong problem-solving, organizational, analytical, and critical thinking skills
• Self-project management and tracking of deliverables with various participants and stakeholders
• Strong communication skills across various cross-functional groups and levels

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.