LanceSoft, Inc. · 1 day ago
Quality Assurance Analyst
Acton, MA, US
Full-time
Onsite
Entry Level
$28/hr - $28/hr
1+ years expLanceSoft, Inc. is seeking a Quality Assurance Analyst to support their quality assurance operations. The role involves managing metrics, conducting product inspections, and ensuring compliance with quality standards.
Information Technology
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
Qualification
Required
Bachelor's degree in engineering or closely related scientific discipline
1+ year of experience in Quality Operations
Excellent data collection and analysis skills
Familiarity with ERP (e.g. SAP) is required
Preferred
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
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
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
H1B Sponsorship
LanceSoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase