Represent Quality on product development teams to ensure products meet corporate quality standards and applicable regulatory requirements
Incoming inspection review and disposition of raw materials and components including non-conforming materials.
Equipment qualification including IQ-OQ: assist project team in developing the protocols and reviewing the executed reports.
Supplier controls: maintain and update the Approved Vendor List (AVL) as needed. Work with project teams to ensure required vendor deliverables are achieved in timely manner.
Production and process controls: review and approve the release of product via batch qualification to support clinical trials.
Test method development: provide support including document approvals of qualifications / validations.
Non-conforming material (NCM) investigations: support all phase of NCMRs from initiation to closure, maintain the database and ensure that timelines are met.
Ensure quality of on-going clinical trials
Promote and enhance the quality process and quality system implementation throughout product life cycle
Execute and deliver on quality assurance related deliverables
Manage external consultants regarding the corporate quality system/audits
Support the development of protocols/reports in support of test method validations, design and process verifications and validations, clinical quality, and risk management
Ensure the implementation and continuous improvement of the quality system including:
Equipment Calibration: maintain the calibration database, manage the external calibration vendor and manage equipment calibration related activities with equipment owners including investigations for calibration failures.
Preventive maintenance (PM): work with project team to determine the required PM and ensure that it is completed as scheduled.
Training: maintain the training database and ensure that required training is properly documented and archived.
Document control: review and process new and revised documents in support of both the quality management system and projects.
Corrective and Preventive Actions (CAPA): support all phases of CAPAs from initiation through Verification of Effectiveness-
Lab notebooks (LNB): issue logbooks, maintain LNB logbook and ensure good documentation practices are adhered to by periodic auditing of lab notebooks and conduct annual reconciliation
Internal audits: as needed conduct or support internal audits.
Third party audits/inspections: support any third-party audits ranging from maintaining the backroom to participation in the audit.
Management Reviews: support the preparation of material for management review and attend the meeting to ensure compliance to internal procedure
Minimum of a Bachelor's Degree in Engineering or Science or related discipline is required.
Minimum of 3-5 years’ experience in Quality Engineering in medical devices. Background in Chemistry is desired.
Proven contributor on product development teams
Experience with ISO 13485 and GMP CFR 820 is preferred
Experience in generating statistically based test plans, writing protocols, and evaluating the results of product and process verification and validation testing
Working knowledge of the US and International standards governing the design, development and manufacture of medical devices
Excellent written and verbal communication skills
Arsenal Medical offers a casual and friendly work environment, shared medical and dental insurance, FSA, HRA, 100% paid STD, LTD, AD&D and Life, 401(k), free-lunch Wednesdays, and more!
About Arsenal Medical
Senior Quality Assurance Engineer
Arsenal Medical currently has an opening for a hands-on, full-time Senior Quality Assurance (QA) Engineer. This person must thrive in a fast-paced environment, be able to work on multiple quality projects simultaneously, and be motivated by the opportunity to learn.
Located in Watertown, MA, Arsenal Medical is mid-stage medical technology company that is transforming medicine through materials science by generating a pipeline of innovative products that improve therapy by treating at the site of injury and disease. Arsenal Medical consists of multi-disciplinary teams, working in close collaboration to create solutions that address some of today’s most challenging and critical unmet clinical needs.
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