Parter Medical Products, Inc. is a leading Manufacturer of single-use plastic products for diagnostic applications and a contract sterilizer of medical products in Carson, CA. The line of products produced and distributed by Parter Medical is marketed throughout the United States and various parts of the world.

We are looking for an experienced, result oriented and hands-on Quality Manager with background in engineering, microbiology or plastic injection molding, and solid experience with FDA QSR, ISO 9000 and ISO 13485 standards to work at our location in Carson California.

Description

The Quality Manager is responsible for all aspects of the quality system throughout our operations. Areas of responsibility include:
• To maintain and refine the company quality systems procedures
• To review and approve all quality records and report activities, summaries and trends to the management team.
• To interact with customers on behalf of the company on matters regarding quality and complaint resolution as well as audits and inspections.
• To administer and perform the internal and external (supplier) audit functions.
• To establish and monitor quality control practices impacting quality of products manufactured and services performed by the company.
• To create, update and implement Standard Operating Procedures, train personnel, conduct internal/external audits
Requirements

Ideal candidates for this position shall meet the following minimum criteria:
• BA or equivalent degree from an accredited university or technical college.
• Actual experience with FDA regulations and ISO certified quality systems such as ISO 9000 and ISO 13485.
• Effective verbal and written communication skills.
• Attention to detail is of the utmost importance.
• Ability to prioritize required functions and ensure on time completion of all required tasks.
• Ability to liaison with different departments to ensure all business and process related tasks are compliant and daily Quality needs are met company-wide.
• Computer literate including strong working knowledge of Microsoft Word, Excel and Outlook.
• Familiar with safety requirements in manufacturing environments.
• Prior experience with medical device sterilization is a great asset.
• Flexibility to work in a 24 hours / 7 days operation environment and understand priorities.

• Location: Carson, CA
• Principals only. Recruiters, please don’t contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.