Operations Quality Technician

Job Title: Operations Quality Technician

Location: Acton MA 01720

Duration: 4+ months (Possibility of Extension & Conversion depending on Performance)

Pay range: $22 to $24/hr

Shifts: Mon-Thurs; 6:00AM to 6.30PM

Responsibilities:
* Inspect and record results of raw materials, work in progress, and finished goods at various stages of the production process to determine and maintain the quality and reliability of our product.
* Assess and complete inspection reports and records including the entry of data into various electronic systems. (For example – Excel, WinSPC, Electronic DHR systems, Oracle Agile, and others)
* Generate, review, and maintain quality records in support of the Quality System. (For example – device history records, non-conformance reports, corrective and preventative actions, internal audits, and training records)
* Review and track lot acceptance records and failure trends.
* Ensure the calibration status of all measuring and critical manufacturing equipment.
* Perform calibration of instrumentation and equipment which supports the manufacture and testing of product
* Assist the Quality Manager in notified body and regulatory authority audits and inspections.
* Works from specifications, work plans, procedures, and general instructions from either Quality Engineers or the Quality Manager.
* Perform internal audits as required.
* Required to perform laboratory activities within a cleanroom setting.
* Required to maintain and enforce cGMPs within the manufacturing operations.
* Safely follow standard operating procedures including but not limited to quality standards, material handling, and record keeping. Must follow all Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs).
* Notifies Quality or Operations Leadership of any discrepancies to ensure quality standards and safety of operations are maintained at all times.
* Able to work in small groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions.
* Maintain a clean work environment suitable for medical device manufacturing and cleanroom production.
* Performs other duties as required

Preferred Skills and Competencies:
* Excels at generating and maintaining organized and accurate records.
* Basic computer skills are required. Proficient use of MS Office products (Excel, Word at a minimum) is a plus.
* 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. The candidate will have an uncompromising adherence to quality standards.
* Experience in 21 CFR part 820 and 11, and ISO 13485 regulations.
* Familiarity with measurement instrumentation such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products.
* Ability to read and understand engineering drawings for machined parts.
* Experience with discreet assembly.
* Experience working in a clean room environment in the medical device industry.
* Experience in a start-up production environment.
* Core Competencies:
* Production & Processing – Knowledge of raw materials, measurement instruments, production processes, quality control, and other techniques for the manufacture and distribution of goods.
* Mathematics – Basic mathematics skills (adding, subtracting, multiplying, dividing)
* Problem Solving – Recognizes problems and understands root cause analysis techniques/concepts.
* Detail Oriented – Excellent attention to detail and good organization
* Autonomy – Capable of working independently with minimal instruction from their supervisor.

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.  
 
Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.