Quality Engineer (Medical Device)

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and Medical Devices.

• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Jobsummary:

• We have an exciting opportunity for a Quality Engineer to work with an upcoming Medical Device company that focuses on Dentistry.
• Summary: The Principal Quality Engineer will be responsible in whole or in part for the effective manufacture of Medical Devices, compliance with internal procedures and external regulations, and the efficient execution of business activities there to related.

Responsibilities:

• Perform related duties as assigned by supervisor Maintain compliance with Quality System procedures and company policies
• Monitor and ensure compliance to internal quality system and external industry regulations
• Manage supplier changes and work with Operations/Quality engineering to evaluate change impact to product performance.
• Lead and drive proactive supplier quality tools e.g. scorecards, supplier risk management and supplier assessments
• Leading and/or supporting supplier related non-conformances and/or CAPAs.
• Execute and support activities to ensure effective monitoring of supplier performance including supplier corrective actions
• Provide technical expertise regarding validations, verification and qualifications
• Develop and maintain inspection and quality control procedures
• Maintain supplier management system, including qualification and audits
• Perform activities pertaining to supplier audits i.e. audit plans, audit execution, audit reports, etc.
• Provide technical expertise regarding component schematics and component inspection requirements Identify improvement opportunities related to the quality system and product; develop quality plans for the resolution of large-scale items
• Participate in and provide technical expertise to project teams

Requirements:

• Minimum B.S. in engineering, life science or related discipline. American Society of Quality Certified Quality Engineer ASQ CQE a plus
• At least five 5 years work experience in a regulated industry Medical Device preferred
• At least three 3 years work experience in Quality Engineering or quality assurance
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
• Excellent computer proficiency MS Office Word, Excel and Outlook Knowledge of US and international regulations FDA, ISO, MDD, etc. pertaining to class II/class IIb Medical Devices
• Ability to lead multi-disciplinary teams
• Demonstrated knowledge of statistical methods and principles
• Ability to create and maintain project plans.
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard practices
• Ability to travel domestically up to 25% of the time

All your information will be kept confidential according to EEO guidelines.