Quality Control Manager

Putnam Plastics Corporation; Dayville (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

Putnam Plastics Corporation in Dayville, CT, is seeking a Manager of Quality Assurance who will oversee quality control procedures, processes, and staff to ensure products meet cgmp and ISO standards in a fast-paced medical device environment.

You will manage resources, schedule work, and drive continuous improvement across the QC group, including CAPA, deviations, change control, and regulatory documentation, collaborating with senior QA leadership.

Qualifications

• Bachelor's degree in a related technical field.
• 10+ years of relevant experience in manufacturing.
• Experience in medical device quality systems preferred.
• Ability to interpret engineering drawings and specifications.
• Strong leadership and communication skills.

Responsibilities

• Oversee quality control procedures, processes and personnel.
• Ensure products meet cgmp and ISO standards.
• Manage resources and planning for all Quality Control employees.
• Lead CAPA, deviation, change control and product quality complaint systems.
• Collaborate with Head of Quality & Regulatory Affairs on regulated documentation.
• Participate in IT projects related to GxP systems.

Skills

Supervisory Experience

Quality Assurance

cgmp & GDPs

FDA 21 CFR 820

SOPs & ISO Standards

ISO 13485

eQMS Systems

Microsoft Office

Education

Bachelor's degree in related technical field

Tools

ETQ

Green Light Guru

MasterControl

Job description

PPC is the industry leading manufacturer of life-saving medical device components for over 42 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 atputnamplastics.com/about/career-opportunities for more information. This is a summary only. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. We are an EEO Employer.

Summary: As the Manager- Quality Assurance,

you will be responsibility for overseeing the quality control procedures, processes, and personnel within our organization, ensuring that our products meet the highest quality standard within cGMPs. This includes the management of the resources and planning for activities for all employees in the Quality control department to assure the highest level of Quality while meeting production demands. Manages activates for continuous improvement and performance enhancement. Includes cross- functional team participation.

Essential Duties & Responsibilities:

• Performs a wide variety of activities to ensure compliance with applicable quality objectives.
• Maintains Quality Control programs to processes to ensure high -quality products and compliance within GMPs and ISO standards.
• Manages competing priorities, allocates and assigns department resources to meet production targets and timelines.
• Assign daily workload to Quality Supervisor
• Oversee the day-to-day functions of In-process Inspection, Final Inspection, and Receiving Inspection.
• Oversee material disposition
• Prioritize, schedule and manage multiple projects and resources simultaneously.
• Assign daily workloads to the Sr. Calibration Technician
• Provide coaching, training, and development in the performance of their duties.
• Develop, revise and implement procedures, work instructions related to Quality Control activities.
• Works with Head of Quality & Regulatory Affairs and Quality Assurance Manager to assist with developing the Company's regulated documentation including SOPs, Templates, and forms.
• May participate as a lead in the CAPA, Deviation, Change control and product quality complaint systems.
• Supports general corporate operations by managing project assigned in accordance with overall company and quality objectives.
• May provide support and participate in IT projects teams related to Quality to ensure development of GxP systems and meet relevant regulations.

Required Qualifications:

• 8 years supervisory experience in a manufacturing or corporate environment.
• Minimum 5 years’ Quality experience in a medical device manufacturing organization.
• Bachelor's degree in related technical and at lease 10 years of relevant experience or the equivalent combination of education.
• Working knowledge of SOP's cGMP & GDPs ISO 13485:2016. FDA 21 CFR820 and other equivalent applicable standards.
• Must possess excellent technical and interpersonal skills to be able to perform each essential duty satisfactorily.
• Excellent Technical and interpersonal skills to be able to perform each essential duty satisfactorily.
• Skills and ability to interpret Engineering Drawings, Specifications in regard to manufacturing.
• Prior Change Management experience within electronic systems (eQMS) such as ETQ, Green Light Guru, Master control Veeva or similar applications and systems.
• Highly proficient in the use of Microsoft Office, including outlook, word, excel, power point, project, visio, sharepoint, teams, and adobe acrobat pro.
• Participates in audits, customer meeting, site visits and inspections and work closely with peer in the organization.
• Training: Responsible to assure that the Quality Control Staffs is trained and shall coordinate with the Training Coordinator to ensure appropriate support is provided.

Preferred Qualifications:

• Bachelor’s Degree in Plastics, Mechanical Engineering, Biomedical Engineering, or Chemical Engineering field and at least 10 years of relevant experience OR the equivalent combination of education.
• 8 years’ experience in a medical device company or similarly regulated environment
• 10 years of related supervisory experience in a medical device company.
• ASQ Certified Quality Technician, ASQ Certified Quality Auditor, ASQ Certified Quality Manager.
• Working knowledge of Statistical Process Control (Minitab), Microsoft Office, plastic extrusion, molding or plastic materials science knowledge, or related experience preferred.

Physical Requirements:

• (With or without the aid of mechanical) The physical requirements described her are representative those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Regularly required to stand, sit, walk use hands to input, able to hear and talk.
• requires data entry and regular use of computer/keyboard/mouse for extended periods of time.
• Generally, works in an office environment and on a manufacturing floor.