Requisition Number: QUALI02185
QMS – Design Control / Change Control
- Support the Quality System processes related to Merz Design Control and Change Control – including, but not limited to: standard operating procedures, risk management files, risk assessments, clinical data, supplier management, labeling and design transfer
- Facilitate, review and/or approve the development of protocols and final reports for new products, design changes, product expansions, transfers or other projects.
- Support other Quality System functions as assigned by Quality Management that are related to documentation creation/revision, training, Nonconformance review, Out of Specification, Corrective and Preventative Actions, product complaint investigations, audits, and other tasks as directed.
- Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.
- Evaluate and implement new technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.
- Participate with federal, state, and local regulatory officials during regulatory inspections.
- Perform internal and vendor quality system audits as applicable
- Bachelor’s Degree required, BS in Engineering or Physical Science preferred
- ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent desirable.
- Minimum 5 years Medical Device or Pharmaceutical Manufacturing and/or other regulated industry or similar experience required.
Knowledge, skills and abilities (incl. languages)
- Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines
- Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, and/or Validation.
- Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information
- Management Systems (LIMS) and Quality Management software is highly preferred.
- Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.
Knowledge or methods
- Ability to prepare testing protocols and reports, operating documents and procedures.
- Familiarity with general laboratory and incoming supply inspection testing.
- Performance of vendor and/or internal audits.
- Computer skills including those associated with the word processing, spread sheet programs, databases and statistical analysis.
- Ability to work with little or no supervision and make effective decisions.
- Handle confidential information with tact and discretion.
- Some clean room work may be required; no make-up or excessive amounts of jewelry allowed.
- Lifting of light to moderately heavy (less than 25 pounds) objects.
- Manual Dexterity