Quality Assurance Specialist II

Shrewsbury, Massachusetts


MARS Solutions Group is looking for an experienced Quality Assurance Specialist II Shrewsbury, MA, USA. Our client is a leading global healthcare technologies and digital solutions company with an enduring and innovative presence in the industry. They foster a challenging and empowering environment that cultivates personal and professional growth.

Role Summary:

• Detail oriented, Prior product release experience, Prior cGMP experience, preferably med device/pharma

Responsible for quality release of finished good products to packaging for shipment.

• Analyze and review manufacturing and test data in written or electronic form to verify accuracy and completeness necessary for the final release. This also includes subcontractor records when product is processed by a 3rd party (i.e. sterilizer records).

• Create tasks in electronic batch record data collection system to resolve product and process discrepancies.

• Issue Certificate of Quality for final product release when all release requirements have been verified and met.

• Provide consultation and guidance to other groups concerning documentation completeness, accuracy as well as related manufacturing quality management systems and processes.

• Collaborate timely with Cross functional teams to aid effective investigations & problems solving

• Interface with manufacturing to coordinate product release activities to best support production build and shipping schedules.

• Provide input for deviations and product concessions. Support Quality Assurance Engineers with deviation, investigation, and rework documentation review.

• Continually identify, recommend and implement process improvements with a lean and quality focus.

• Comply with EHS regulations & policies.

• Responding to routine quality related queries from other departments.

• Monitoring and aiding the implementation of continuous improvements and process changes to ensure these are implemented in compliance with GMP.

• Demonstrated knowledge of Quality Management System Tools and continuous improvement methodologies.

• Demonstrated collaboration, negotiation & conflict resolution skills.

• Effective communication skills (written and oral).

• Ability to multi-task & handle tasks with competing priorities effectively.

• Technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).

• Experience with generating, tracking and interpreting quality metrics.

• Demonstrate support to a positive quality culture

• 1-year experience in a medical device or pharmaceutical industry.

• 1-year experience with CAPA systems, including complaint handling.

• Thorough familiarity with cGMPs

• Knowledge of relevant Electronic Management Systems transactions and familiarity with Excel / Word packages.

About MARS Solutions Group:

MARS Solutions Group provides a range of opportunities for meaningful work by understanding that employment fit is a combination of people, process, and technology. We leverage our experienced and compassionate team to bring humanity to matching you with the right advanced technology role, and stay connected with you to help you attain your professional goals.