Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
Title:Field Assurance Analyst Returns Technician
Duration: 06 months
Location: Warwick, RI
Pay: $25/hr on w2
Summary/Purpose of Position:
Under the leadership and general supervision of the AQE Lab supervisor and Field Assurance Manager, the
Field Assurance Analyst Returns Technician will be responsible for the execution of product complaint
sample return evaluation and investigation activities while ensuring complaint handling tasks are completed
as required and are compliant with internal procedures and applicable external, industry
regulations/standards. Additionally, the technician will perform lab duties to support New Product
Development in the AQE Lab.
Essential Duties and Position Responsibilities: /
Field Assurance Duties
Documenting complaint product sample return date.
Decontaminate returned product samples.
Coordinate product transfers to/from external manufacturing sites.
Evaluate and investigate product sample returns to assist in determining the most probable
root cause of the complaint and document accurate investigation findings in the complaint
handling system.
Maintain the Field Assurance (Bio-Hazard) Lab area. Ensure Lab is clean and in good order.
Items are properly labeled as potential biohazard material as received.
Support lab biohazard waste disposal in conjunction with facilities.
Manage and document thorough and accurate complaint records while ensuring they are
processed in a uniform and timely manner and are compliant with Good Documentation
Practices (GDP).
Identify and escalate quality issues and identify changes in (MDR/MDV) reportability based
on sample return condition.
Support internal and external audits and serve as an active participant as necessary.
Complete mandatory training by established due dates and always maintain training
compliance.
Adhere to departmental processes and systems to ensure regulatory compliance.
AQE Lab Duties
Assists with the inspections and evaluations for new product development projects and first
article inspections to support the component qualification process.
Perform accurate mechanical, physical, and visual inspections of raw materials and
components on time, as per Inspection Plans and Specification RequirementsRead and interpret specifications and part prints, including Geometric Dimensioning &
Tolerances (GD&T).
Review and complete inspection records, lab requests, and device history records as per
GMP requirements.
Performs and coordinates inspections based on business priorities and coordinates with
other departments as needed.
Qualifications, Knowledge, and Skills Required:
Associates degree required. BS/BA preferred.
2-5 years of experience in complaint handling, quality control, manufacturing or related functions in
the medical device, pharmaceutical, biotech or equivalent industry.
Sound written and verbal communication skills are required.
Proficiency in common computer applications such as Microsoft Office (Excel, Word and Outlook).
Familiarity with medical, anatomical and physiological terminology preferred.
Familiarity with the medical device industry and regulatory requirements preferred.
Duties require basic knowledge of mechanical and physical inspection techniques. (Calipers,
micrometers, blueprint reading, etc.)
Duties require knowledge of inspection/sampling techniques and familiarity with ANSI/ASQZ1.4.
Knowledge of FDA Quality System Regulations, ISO 9000, and ISO 13485
Key Relationships:
Internal Relationships: External Relationships:
– Field Assurance Personnel – BDI Surgery manufacturing facilities
– Advanced Quality Engineers – OEM manufacturing facilities
– R & D Engineers
Why work with us – At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
America’s Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
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