This position is responsible for performing Quality Assurance tasks and activities with guidance and supervision. Has
knowledge of commonly used concepts, practices, and procedures within quality assurance field. Relies on personal
experience and judgment to perform primary job responsibilities. This role is an Independent Contributor with no direct
reports. Interaction is potentially with all levels of the organization. Progression path would be to a senior level Quality
Engineer based on performance, development, and experience. This position reports to a more senior Quality Engineer,
Assistant Manager or Quality Manager.
Participates in design and development project meetings as the Quality representative supporting compliance and PMI
Quality position in product design and documentation.
Supports compliance to Good Documentation Practices during assigned document reviews.
Responsible for at least one set of document management and program maintenance functions such as batch cards, MIs,
DHR, DMR, DMF,CAPA, ECO, Validations, IP/PS, customer complaints, FMEA, Customer Proposals, Drawings,
Design Control, SDS’, Calibrations, NCR, Product shipping and Label Control.
Participate in customer and regulatory audits as well as internal audits. When trained may be internal or external auditor.
For this some travel may be required.
Responsible for the ISO 13485 and cGMP compliance of the assigned PMI programs.
Meet annual Quality Objectives as set with manager as well as assigned Quality metrics.
Recommends and implements Quality process improvements with the approval of Quality Manager
Perform validations or participate in validation teams or work on analytical equipment as requested.
Required Knowledge, Skills and Abilities
Fluency with Microsoft Office Software (Microsoft Word, Excel, et. al.)
Excellent technical writing skills, grammar, proof reading skills
Excellent organizational skills, attention to detail, ability to manage time and prioritize
Ability to think proactively, troubleshoot, investigate and improve systems
Excellent communication and interpersonal skills, able to assertively interact with people at all levels of the organization
Ability to lead projects and train others as required
Ability to handle confidential business information
Required – Bachelor’s Degree in chemical, plastics or polymer engineering.
Preferred – At least 1 year experience in medical device, pharmaceutical or similarly cGMP/ISO regulated industry