Quality Engineer in Webster, MA

Webster, Massachusetts
Job Type
US$ 60,000 - US$ 70,000 per year, $60k - 70k per year + none
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, cGMP, FDA 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.
- Reviews Engineering documents including IQ, OQ, PQ/PV documents for manufacturing equipment and facility utilities
- Reviews and approves nonconformance reporting, investigations and CAPAs associated with incoming, in process and production batch processing.
- Provides guidance and direction to less experienced staff.
- Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
- Responsible for quality presence, release of materials, and finished product, investigations and nonconformances, CAPA, complaints, supplier management and supporting Management Review.
- Provide leadership, guidance and problem solving skills to employees within the department and as a member of cross functional teams.
- Assists with preparing for and participating in customer and regulatory agency inspections, e.g. FDA, ISO, EMEA, etc

Working hours: 7:00am - 4:00pm

--Strong 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.

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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