approval, material receiving, internal audit process ad document control. Requires experience in ISO-9001/ISO 13485 or c GMP manufacturing environment plus demonstrated familiarity with standard quality concepts. 2.0 Supervisory Responsibilities: None. 3.0 Position Requirements: Note: Qualifications are based upon education, resume and/or work experience.
3.1 Minimum of 3 years of experience. 3.2 Possess a great attention to detail. 3.3 Must be able to work independently with minimal direction or oversight. 3.4 Must be able to maintain accurate and organized records. 3.5 Windows-based computer skills, familiarity with Microsoft Word and Excel. 3.6 Good organizational skills with ability
to manage multiple priorities. 4.0 Responsibilities include (but are not limited to): 4.1 Must be able to take a leadership role in Quality related decisions. 4.2 Proactively ensure batch records are reviewed prior to material release, ensuring paperwork is completed accurately, neatly and fully.
4.3 Performs through root cause analysis and establishes in-depth and robust corrective and preventative actions for both internal non-conformances and customer complaints. 4.4 backsses materials received against internal procedures and performs the necessary approval to release materials. 4.5 Ability to read unplanned deviations, change controls, validations and other technical documents/reports
to identify errors and/or potential non-compliance issues and to backss potential product/process risk.
4.6 Complete supplier approval paperwork for new incoming suppliers 4.7 Participate in internal audits and inspections including planning for audits, execution, and follow-up on audit findings. 4.8 Assists in the tracking and maintenance of document control activities. 4.9 Write, revise and review standard operating procedures (SOPs) and custom specifications. 4.10 Become thoroughly knowledgeable of the applicable SOPs and maintain that knowledge base. 4.11 Other duties as assigned 5.0 Education: 5.1 4 year college degree in quality/compliance related field or science-related field with 2-4 years related experience.
6.0 Physical Requirements: 6.1 Prolonged periods of sitting at a desk and working on a computer. 6.2 Must be able to lift up to 25 pounds at a time. 6.3 Must be able to access and navigate each department at the organization's facilities. 7.0 Working Conditions: 7.1 Conditions inside the office is generally quiet, periodically there may be mid-level noise from various equipment when traveling to other facilities.
