Title: Quality Assurance Analyst (Only W2, No C2C- Local to MA Only)
Duration: 6+Months
Location: Acton, MA
Must be onsite 5 days a week.
Position Overview:
The Quality Assurance Analyst will work under the guidance of the Quality Assurance Manager to manage the weekly, monthly and quarterly metrics for all locations. This includes collecting, analyzing and presenting data to various forums for operations review, MRB and management review. The Analyst would also be responsible for lot release approvals in SAP and any stock movements and adjustments to be made.
Responsibilities:
Maintain documentation database.
Control the flow of documents to support manufacturing, as required .
Perform pre-sterile and post-sterile lot qualification metrics monthly.
Manage NCMR and quarantine metrics, as required .
Responsible for collecting information related to metrics for various forums on a monthly and quarterly basis.
Collect information related to NCMRs, Quarantine, IQA, lot qual & lot release metrics for material review board (MRB) review on weekly basis.
Support product release initiatives and tasks as needed.
Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables
Provide training and support to quality assurance team members that covers systems, policies, procedures, and core processes
Interpret, build upon, and comply with company quality assurance standards
Maintain complaint and nonconformance processing through records and tracking systems, including root-cause analysis and corrective actions
Document quality assurance activities with internal reporting and audits
Review lot results from the DHR Coordinator Quality and decide whether they can accept the lot.
Make required stock movements and adjustments in SAP as needed.
Education and Experience: Minimum Requirements:
Bachelor s degree in engineering or closely related scientific discipline.
1+ year of experience in Quality Operations
Excellent data collection and analysis skills
Preferred Skills and Competencies:
Medical device or related industry experience in a technical position.
Working knowledge of the Quality System Regulation (FDA 21CFR Part 820) and ISO 13485 quality system standards.
Strong verbal and written communication skills, internal and external to the company.
The ability to prioritize multiple competing deliverables simultaneously.
Demonstrated knowledge of Microsoft Access.
Expert knowledge of Microsoft Word, Excel, Outlook and Power Point.
Knowledge of Configuration Data Management requirements for engineering documentation a plus but is not required .
Working knowledge of documentation functions of a medical device company preferred.
Familiarity with ERP ( e.g. SAP) is required .
Any Quality certifications a plus.
Effective written and verbal communication skills.
Ability to communicate at all organizational levels.
Ability to organize and judge priorities.
Ability to generate and maintain accurate records.
Comfortable communicating to all levels and functions.
Must have strong clerical skills (filing, alphabetization, etc.).
Very strong organizational skills.
Very strong attention to detail.
Able to work in a team environment
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