Software Guidance & Assistance, Inc., (SGA), is searching for a QA Engineer - Quality Systems (Medical Device) for a contract assignment with one of our premier BioTech services clients in Cambridge, MA.
Onsite 4-12 days a month, based on need.
Responsibilities :
The Associate QA Engineer works within the Quality Systems department at the firm and collaborates with various teams across the firm. This role partners with all parts of the organization to ensure that the firm's Quality Management System, CAPA's and Non-conformances processes are effective and compliant. This position supports Quality team members in achieving all related business goals.
- Support Quality Management System.
- Support the implementation of continuous improvement and harmonization of the quality system across all sites.
- Effectively collaborate cross-functionally to facilitate the completion of documents.
- Maintain Quality Management Systems for functional area including Design Controls, Software, Development, Risk Management, Corrective and Preventative Action (CAPA) system and NonConforming Material Reports.
- Support root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
- Be responsible for developing, measuring, and monitoring key performance indicators.
- Other duties as assigned.
Required Skills:
- Bachelor's Degree; OR,
- 5+ years of equivalent related experience.
- Degree in the Sciences, Engineering or Business-related field.
- Experience with IVD or Medical Device Quality Systems.
- Knowledge of standards and regulations pertaining to the IVD and/or Medical Device industry, both domestic and international and not limited to FDA QSR 820, ISO13485, ISO15189, CAP/CLIA, & IVD/IVDR
- Knowledge of CAPA and Root Cause Investigations.
- Knowledge of Good Manufacturing Practices.
- Ability to communicate, interact and influence effectively regarding quality system processes.
- Ability to work in a fast-paced environment with high attention to detail.
- Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
- Good communication skills and ability to work effectively as a member of a multidisciplinary team.
- Understanding of HIPAA and importance of privacy of patient data.
- Commitment to the firm's values: patients, innovation, collaboration, and passion.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.