3525 - 3201 - QC Specialist II
About The Position
Perform necessary functions, including testing and inspecting products at various stages of the production process to ensure and maintain high quality and reliability of materials and products. Establish and maintain device master records to include monitoring product labeling and inserts. Perform periodic in-house inspections to ensure compliance to procedures. Assist in handling customer complaints regarding products; including completing necessary paperwork and correspondence in a timely manner. Conduct operations in accordance with safety requirements. Review new products and proposed changes to existing products. Coordinate sterilization validations and product testing, if required. Notify vendors of quality issues and submits samples as necessary. Perform in-process and/or final inspections of products on a daily basis. Consolidate and present information for corrective and preventive action (CAPA) meetings. Work with manufacturing staff on quality-related issues; Train work force as required in quality standards and procedures. Participate in vendor and/or internal audits, as required; Assist in performing corrective actions for internal and external audits. Originate and maintain raw material specification files; Perform raw material inspections.
Requirements
- Associate degree with one to two years related experience and/or training; or High school diploma or equivalent (GED) with two to four years related experience and/or training; or equivalent combination of education and experience.
- Ability to use ten-key, fax machine, office copier and computer.
- Experience in Microsoft office.
- Good organizational skills.
- Ability to work well under limited supervision.
- Professional attitude and appearance.
- Flexibility, dependability and the willingness to take direction.
- Excellent phone skills.
- Positive attitude.
- Ability to be flexible with job duties and hours.
- Skill meeting deadlines.
- Ability to interact with employees representing all levels of the organization.
Nice To Haves
- Knowledge of JDE
Responsibilities
- Testing and inspecting products at various stages of the production process.
- Establishing and maintaining device master records.
- Monitoring product labeling and inserts.
- Performing periodic in-house inspections to ensure compliance to procedures.
- Assisting in handling customer complaints regarding products.
- Conducting operations in accordance with safety requirements.
- Reviewing new products and proposed changes to existing products.
- Coordinating sterilization validations and product testing.
- Notifying vendors of quality issues and submitting samples.
- Performing in-process and/or final inspections of products.
- Consolidating and presenting information for corrective and preventive action (CAPA) meetings.
- Working with manufacturing staff on quality-related issues.
- Training work force in quality standards and procedures.
- Participating in vendor and/or internal audits.
- Assisting in performing corrective actions for internal and external audits.
- Originating and maintaining raw material specification files.
- Performing raw material inspections.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
