What are the responsibilities and job description for the Quality Assurance Lead position at Iterative Scopes?
Quality Assurance Lead
Department: Regulatory
Employment Type: Full Time
Location: Cambridge, MA
Description
The Quality Assurance Lead position will maintain the Quality standards of the company’s products or services by ensuring adherence to company policies, regulatory guidance and client specific requirements. The Quality Assurance Lead will manage audits; assess and approve deviations, change controls, CAPA etc., and will also support Quality system activities related to Management Reviews and Quality Review Boards.
The Quality System Lead will work closely with leaders across Iterative Scopes to help the company set and adhere to its QMS. This is a great opportunity for anyone interested in taking a lead role in quality assurance and system compliance for a fast-growing medical device company.
Key Responsibilities
- Coordinate documentation management activities using electronic documentation management system
- Lead the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and regulatory compliance of the products manufactured by the company
- Track key Quality System Performance Indicators (KPI) required to meet Quality Objectives with management guidance
- Lead the internal audit system to ensure continued compliance to domestic and international regulatory regulations
- Responsible for corrective and preventive system to ensure continued compliance to domestic and international regulatory regulations
- Establish and coordinate the company training program to ensure that new personnel are trained to the cGMP and ISO requirements specific to their job responsibilities as well as regular assessments
- Perform the review and approval of batch related documentation to support product release
- Perform duties regarding special projects, as assigned by management
- Support investigation of both technical and compliance issues/gaps
- Supports follows-up and closure of Management Review action items
- Responsible for standards management
- Lead FDA inspection readiness efforts
Qualifications
Minimum Qualifications:
- Bachelor’s degree in technical or related field
- 3 years of demonstrated practical Quality Systems or Quality Assurance experience
- Proficiency with Google Docs and/or Microsoft Office tools (Excel, Word, PowerPoint, Outlook)
Desired Qualifications:
- Experience with electronic quality management systems software
- Software as Medical Device (SaMD) experience
- Self-directed – able to work at all levels of the organization – “hands on” management to accomplish goals
- Experience with ISO14971, ISO 62304, ISO 62388
- ASQ/ISO Certified Auditor
- Experience with durable equipment medical device manufacturing or product development
- Experience leading, training and/or implementing root cause analysis and effective investigation practices
- Strong verbal and written skills
- Routinely exercises sound judgment, reasoning and problem solving
- Capable of timely completing assigned responsibilities under minimal supervision
- Flexible and able to respond quickly to shifting priorities and meet deadlines
- Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential
Benefits
- Vision/Dental/Medical Insurance
- Life/Disability Insurance
- Maternity/Paternity Leave
- Stock Options
- Flexible Work Hours
- Unlimited Paid Time Off
- Fun Workspace! (Standing Desks, Balance Boards, Ping Pong Table, Pick your own workstation set-ups!)
- Free Snacks and Drinks (Jura Espresso Maker Snacks upon requests!)
- Free lunch on Fridays
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