Specialist - Quality

Putnam Plastics Corporation (PPC) is the industry leading manufacture of life-saving medical devices components for over 40 years. We are looking for people who want to invest in their future, the future of PPC and our PPC community. Please refer to our website at putnamplastics.com/about/career-opportunities for more information. This is a summary only. We are an EEO employer.

The Quality Specialist completes administrative, and clerical activates in support of the Quality Assurance Group. This includes processing customer compliance inquires such as REACH & RoHS request, processing customer Feedback and complaints, processing both internal and external change requests, as well as administration of documents, record control, and training process. The Quality Specialist actively participates in continuous improvement initiatives as assigned and offers and supports ideas of improvement.

Essential Duties & Responsibilities:

• Receives, enters and processes, customer regulatory and quality system compliance requests.
• Communicate with customers regarding details of status of open compliance requests.
• Customer feedback: Receives, logs and process customer feedback and review with team.
• Track and report performance metrics pertaining to customer feedback.
• Maintain applicable work instructions in order to ensure that they accurately describe processes.
• Reviews, processes and maintains documents and records within the QMS.
• Considers, coordinates and communicates Customer Change Notifications to internal and external customers.
• Controls and tracks the distribution of internal and external documents and records.
• Supports Planning, Execution, and documentation of PPC training. Reviews applicable work instruction to ensure that they accurately describe current processes. Supports Regulatory, Internal and Customer Audit as needed.
• Track and report performance metrics pertaining to QMS processes.

Required Qualifications:

• High School Diploma, GED or relative work experience in an administrative position.
• General understanding of QMS processes.
• Strong analytical and critical thinking skills.
• Attention to detail which is critical in documenting and reporting.
• Excellent verbal, written and communication skills. Able to read/write and understand English and interpret documents.
• Solid experience with Microsoft Office, especially Word and Excel. Able to use PPC’s computer software for quality and production.

Preferred Qualifications:

• Degreed with two or more years' previous years of related Quality or Customer Service experience.
• Applicable professional certifications (ex. Certified Risk and Compliance Management Professional (CRCMP).
• Previous experience with ISO, FDA, and/or cGMP, controlled environments with established QMS.
• Knowledge of regulatory standards such as REACH SVHC and RoHS.

Physical Requirements: (with or without the aid of mechanical) Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Required to sit for majority of work shift. Position requires data entry and regular use of computer/keyboard/ mouse. Periodically, overtime may be required by this job may include weekends. Cross training will be required.
• Maybe required to lift up to 50 lbs.