Title : Quality Specialist

Duration: 8+ months Contract -Possibility of extension

Location: Lexington MA 02421.

Must haves :

• Document review position
• Attention to detail is paramount
• if they have inventory management software experience (JDE, Oracle) then that would also be great
• Familiarity with calibration
• How to read calibration

Job Description:

Summary/Purpose of Position
Responsible for ensuring that all raw materials and products batch records are reviewed and released in a timely manner and in compliance with all Quality requirements. Assist in Calibration, Environmental Monitoring Reviews and Preventive Maintenance Administrator. The Quality Specialist will support the Quality Systems such as: Audits, CAPA and Management Review.

Duties involve using different procedures, requiring the use of judgment and analysis of facts to determine action to be taken within the limits of established acceptance standards. Additionally, requires a sense of urgency regarding the matter of serving the customer and compliance needs.

Essential Duties and Position Responsibilities:
Performs independent review of textile raw materials and subassemblies including yarns, fabrics, and tubular fabrics for conformance to specifications, including calculation of results using formulas and Excel spreadsheets. Ensures that all product lots meet the established in-process procedures, specifications and inspections, before his/her approval to release.
Ensures that completed lot history records submitted for lot release review are secured prior to disposition. Responsible for timely completion of final product shipping authorization documentation.
Maintain and file the lot history records and release activities documentation.
Conducts Data and documentation review and analysis.
Maintains receiving inspection, work in process and finished product DHR records, procedures, and specifications. Review lot history folders for final lot release sign off and files them in the appropriate location.
Review a database with all yarn and chemical re-test dates required by the specification.
Assist in writing inspection and test procedures and other documents relevant to incoming/receiving inspection, work in process, finished product and Lot Release.
Assists coordination of calibrations. Maintains calibration log and coordinate calibration of the respective gauges and equipment.
Assist in the environmental monitoring reviews.
Support the Quality Systems such as: Audits, CAPA and preparation of the Management Review deck.
Assist Quality Manager/Quality Engineer in data collection, review, analysis and reports as necessary (related to re-works, sorting, lot release, inspection process time studies and etc.).
Reviews device history records and associated documentation in preparation for lot release to shipping, maintains lot release records with high degree of legibility, accuracy, neatness and organization.
Follow established company rules and regulations, safety precautions, and maintain quality standards.
Regular attendance and punctuality.
Assist in maintaining supplier quality database. Perform data entry and generate monthly supplier history reports.
Perform reviews and inspections of new and existing products as needed.
Assist Quality Engineer by providing input for test procedures and test protocols.
Maintain neat and accurate records for all testing performed.
Computerize and analyze results of studies using software packages such as Windows, Excel, Word and Statistical analysis software.
Perform other related duties as assigned.

Qualifications, Knowledge, and Skills Required:
Associates degree in Sciences or related discipline or High School diploma and minimum 4 years of relevant Quality experience required
Two or more years of experience working in a medical device or other regulated industry
Must have ability to read, write, interpret, comprehend, and consistently follow specifications written in English
Must have strong attention to detail
Ability to manage multiple priorities and tasks in a dynamic environment
Ability to work in a team environment
Computer literacy particularly with databases and spreadsheets / basic ability to use Microsoft Office required
Good oral and written communication skills. Ability to coordinate work cross functionally.
Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)