About the role
Responsible for Document Control and Records Retention.
Trends data from Quality System inputs and creates monthly charts and reports.
Assists in Quality Management Review preparation.
Assists with Failure Investigations (Complaint, Non-Conformance, Supplier, etc.)
Participates in internal audit program.
Works with Quality and Operations management on short and long term quality planning and quality system improvements initiatives.
Drafting new, and revising existing Standard Operating Procedures (SOP)
Approval to ship conforming product following full review of process documentation.
Make records of quality activities per specified procedures.
Maintain all required documentation of work performed and ensure that all forms and materials are labeled properly.
BASIC QUALIFICATIONS:
- BS/BA Degree in a scientific/technical field and 2+ years working in a regulated environment.
OR
- AS Degree in a scientific/technical field and 4+ years working in a regulated environment.
PERFERRED QUALIFICATIONS:
- ASQ Certifications a plus.
- Working with Pharma or Medical Devices preferred
- Experience with ISO 13485 or ISO9001 preferred.
- Demonstrated ability to work effectively and positively with all levels of an organization.
- Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
- Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
- Strong organization skills required.
WORK ENVIRONMENT:
- Temperature controlled office and manufacturing environment with large printing and related equipment.
PHYSICAL REQUIREMENTS:
- Sitting, standing, walking, stooping, bending, squatting, leaning, climbing stairs and ability to lift 40 pounds.