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Access Vascular, Inc. · 1 day ago

Document Control Specialist

Billerica, MA

Full-time

Onsite

Mid Level

$65K/yr - $85K/yr

3+ years exp

Access Vascular is a company focused on developing innovative venous access devices to minimize complications associated with intravenous therapy. The Document Control Specialist will be responsible for creating and managing quality documentation and overseeing the Quality Management System to ensure compliance with regulations and standards.

Advanced MaterialsHealth CareManufacturingMedical DeviceProduct Management

Responsibilities

Ensure the consistency and quality of AVI product, process, and policy documentation in strict compliance to corporate policies, regulations and standards, from document creation to hard-copy and electronic filing to document obsolescence

Assist technical team in the use of documentation standards, such as protocols, reports, procedures, material and assembly specifications, customer documentation, and product labeling

Ensure the consistency and quality of documents with the change control process

Identify, generate and publish Quality metric reports related to Document Control and Training

Facilitates the effective processing of quality system documents to ensure they are maintained and archived in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body

Establishes and maintains library of product and process-related reference standards, regulations, guidances, clinical articles and journals

Support the AVI Quality Management System as required, including continuously streamlining and improving QMS procedures and supporting Internal and External Audits

Qualification

Document ControlQuality Management SystemMedical Device StandardsElectronic Documentation SystemsMicrosoft OfficeAdobe AcrobatCommunication SkillsOrganizational Skills

Required

A minimum of 3 years of experience in a medical device design/manufacturer environment responsible for documentation control

Minimum of an Associate's Degree in a Science or Technical discipline

Multiple certifications specific to medical device quality and/or standards may be considered for a non-degreed professional, along with equivalent industry experience

Familiarity with documents that support the following in a medical device environment: new product development (protocols, reports, software, validation data, Design History Files), quality system (procedures, forms, quality records), and manufacturing (Device Master Record, Bills of Material, routers, procedures, Device History Records) documentation

Past experience with electronic documentation control systems

Strong verbal and written communication skills and effective interpersonal skills

Ability to multitask, prioritize and meet deadlines

Must be able to work independently or as part of a team

Experience in data entry, handling electronic files

Above average organizational skills, detail-oriented while being flexible, able to adapt to changing priorities

Proficiency with Microsoft Office, Access, Visio, Project