Quality Engineer

Putnam, Connecticut
Manufacturing & Production (Production Occupations)
Job Type
Temp to Perm
US$ 16.00 - US$ 17.00 per hour
Ref. Number
Silva, Kristi, Spherion
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Job Description

Maintains quality presence; releases raw materials, in-process materials, and finished product; supports investigations and works with owning departments to resolve deviations and complaints; conducts annual product reviews throughout the Delivery Science organization. Assures the quality of manufactured products is compliant with all applicable regulations and guidelines. Assists with preparing for and hosting of Regulatory and customer audits.
Implements and maintains quality systems, policies and procedures that ensure compliance to ISO 13485, cGMP, FDA (i.e. 21CFR11, 820, 210, 211) and other applicable standards.
Performs complex manufacturing batch production record reviews and approval in support of product release in accordance with specifications and procedures.
Samples, inspects, and releases consumable items and manufacturing components per specifications.
Monitors various stages of processing along with the appropriate paperwork in compliance with specifications and procedures.
Drafts and reviews specifications and procedures

Working hours: 11pm - 7am

Background and demonstrated effectiveness in quality assurance operation and compliance
of commercial medical device / pharmaceutical in an ISO and FDA regulated environment
Knowledge of plastics manufacturing, analytical testing is highly desirable.
Extensive knowledge of ISO, US and EU cGMP regulations
Knowledge of pharmaceutical and finished product manufacturing, analytical testing is desirable
Knowledge of electronic manufacturing support systems including any of the following: ERP and
QMS desirable
Experience with FDA Preapproval Inspection preparation and management is essential.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Familiarity with the tools, concepts and methodologies of Quality Management Systems.
Analytical, problem solving, and decision making skills (i.e. DMAIC, FMEA, DOE, SPC,
- Attention to detail is crucial in this position
Able to work closely with all other departments within Foster Delivery Science
Able to work closely with all customers and suppliers
Flexible in handling multiple and changing work assignments on a daily basis
Self-reliant in meeting goals and objectives
Ability to effectively present information and respond to questions from groups of managers and

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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