Job title: Quality Assurance Engineer – 100% Remote
Duration: 6 months
 
I. SUMMARY:

• This description outlines the employment prerequisites and job responsibilities for the position of Engineer, Quality Complaint Investigations.

 
II. ESSENTIAL FUNCTIONS:
This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.

• Review individual complaints and associated service data to determine risk level and complete investigation into the “as “determined” problem code and cause codes for each complaint.
• Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis.
• Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
• Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.
• Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
• Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
• Support CAPA and maintenance activities for existing product lines.
• Recommend and/or support projects for improvements to the quality system as approved by management.

 
III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED
To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.

• Medical Device Experience with knowledge of 21CFR820 preferred.
• Investigational research skills
• Experience with any statistical software packages (Minitab a plus)
• Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
• Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional).
• Knowledge and working application of reading and understanding blueprints and technical drawings.
• Demonstrated strong analytical problem solving (Root Cause Investigations.
• Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
• Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
• Ability to multi-task and methodically manage projects.

 
IV. EDUCATION/EXPERIENCE REQUIRED

• A Bachelor’s degree in Engineering and 1-3 years of Medical Device experience

 
V. PHYSICAL DEMANDS

• Able to exert up to 10 pounds of force occasionally.
• Able to sit, stand, walk throughout the workday.

 
VI. WORK ENVIRONMENT:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
The company is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:

• Wearing a static protective smock at all times while in the manufacturing work area
• Working in close proximity to other employees.
• Working in an environment that is temperature and humidity controlled.

 

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
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: $33.00/hr.