Quality Associate Monday-Friday 0800-1700

Position Summary:

• Serves as primary reviewer for DHR documents and product release
• Quality assurance process improvements
• Prepares DHRs and labels to be used by Production
• Coordinates incoming inspection activities and release of production components, raw materials, as well as related corresponding documentation for use in manufacturing operations
• Assists with additional work duties or responsibilities as evident or required.

Primary Responsibilities:

• Review Device History Records to ensure its completeness and accuracy, and as appropriate follow-up any correction needed.
• Conduct product release for Nephron Nitrile, by ensuring that required testing and documentation is closed and complete.
• Coordinate with Quality Management to communicate lot release priorities, re-work status updates and production disposition.
• Responsible for sampling and releasing production components and raw material chemicals.
• Ensures production components, raw material chemicals, and corresponding documentation provided by warehouse personnel are processed and stored per procedure.
• Ensures sample collection for incoming inspection based on applicable procedures.
• Ensures all documentation and data entry is completed and reviewed (raw material chemicals, production component folders, etc.) to release or reject based on inspection/testing results.
• As needed, receive incoming Raw Materials/Production components and verify BOL and ASL, COA, and sample material for release.
• Update the NetSuite Software for conditions and statuses of PC, RM and for Lot release, also create RM numbers for all raw material and PC received.
• Generate performance reports for the activities in scope as per management needs

Knowledge, Skills & Abilities:

NOTE: The primary accountabilities and knowledge, skills and abilities listed below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• High School diploma with Bachelor of Arts or Science degree preferred
• 3 years of relevant experience in document review and product release in manufacturing settings (2-5 years preferred)
• Prior knowledge of general Quality Management Systems (e.g. ISO 9001, FDA regulations) is strongly recommended
• 2-5 years of experience MS Word, Excel, and PowerPoint.
• Written and Oral communication skills.
• Team Player must be able to interact within all departments of the company.
• Ability to work independently; dependable.
• Strong attention to detail.
• Specific expertise, skills and knowledge within quality assurance gained through education and experience.
• The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Position requires lifting (up to 40 lbs.), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing and hearing.
• Incumbents required to wear specified protective equipment as necessary.