Job#: 3037080

Job Description:

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.

Apex has an opportunity for a Validation Quality Technician. For applicants who are interested in this opportunity, send your updated resume to [email protected].

Here are the details:

Position: Validation Quality Technician

Location: Acton, MA

Project Duration: 5 months

Rate: Negotiable Based on Experience

JOB DESCRIPTION

Position Overview:  

The Quality Technician is responsible for executing Test Method Validations, Process Validations, and other engineering studies in accordance with written protocols and procedures to maintain the validated state of our client's product manufacturing and quality processes. The Quality Technician collaborates with Quality Engineering to ensure new and existing products conform to the client Quality System, Quality System Regulation, ISO 13485 and ISO14971 throughout the design transfer to manufacturing process as well as product lifecycle. He/she is responsible for maintaining strong Quality Records in compliance with Good Documentation Practices (GDP). He/she will serve as a Quality representative on wide scale remediation efforts to ensure compliance to both internal and external requirements in areas including process risk management, test method validation, and process validation. 

Responsibilities:  

• Follow validation and verification protocols to execute engineering studies, process validation, test method validation (Gage R&R and Attribute Agreement Analysis), and process verification studies. 
• Enter and maintain data in compliance with internal and external Quality Records requirements, following Good Documentation Practices (GDP). 
• Excellent attention to detail, good organization, and capable of working independently with minimal instruction from production supervisor. 
• Able to work in small groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions. 
• Performs other duties as required 

Education and Experience: 

• High School Diploma or GED 
• Experience in Quality in an FDA regulated industry. 
• Experience with performing test method validation and process validation of medical device products. 
• Experience with word processing, spreadsheet, database programs. 

Skills and Competencies: 

• Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment. 
• Must be proficient in English language to be able to read documentation, communicate, and write. 
• Ideal candidate will have keen eye for quality, is dependable, and will work collaboratively within a team, and possess a positive attitude. 
• Previous experience working in a clean room environment. 
• Manufacturing and/or inspection experience in a regulated industry is a plus. 
• Knowledge of raw materials, measurement instruments, production processes, quality control, and other techniques for the manufacture / inspection of medical devices. 
• Recognizes problems and understands root cause analysis techniques/concepts. 
• Experience with ETO sterilization methods preferred. 
• Ability to generate and maintain accurate records. 
• Ability to follow up with task owners to close out open items. 
•  

Physical Requirements (if applicable): 

• Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift. 

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at https://www.apexsystems.com/privacy-policy

Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at [email protected] or 804-523-8228. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex Systems.