Quality Assurance Manager

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

Benefits offered by this job

Medical, Dental, Disability & Life-Ins

Paid Vacation & Holidays

On-site Fitness Center & Wellness

Shift Differentials

401K with Company Match

Bonuses

Tuition Reimbursement

Private, Family Owned Company

USA-based operation

Job summary

Putnam Plastics Corporation in Dayville, CT is seeking a Manager of Quality Assurance to oversee quality control procedures, ensuring products meet cGMP and ISO standards while leading a cross-functional team.

The role requires extensive supervisory experience in medical device manufacturing, deep knowledge of SOPs and regulatory requirements, and a focus on continuous improvement. It's a private, family-owned firm with growth opportunities.

Qualifications

• 8+ years supervisory experience in a manufacturing or corporate setting.
• Minimum 5 years of quality experience in a medical device manufacturing organization.
• Bachelor's degree in a related technical field or equivalent experience.
• Working knowledge of SOPs, cGMP, GDPs, ISO 13485:2016, FDA 21 CFR 820.

Responsibilities

• Oversee quality control procedures and personnel to meet product quality standards.
• Maintain Quality Control programs compliant with GMPs and ISO standards.
• Prioritize and allocate department resources to meet production targets.

Skills

Supervisory leadership

Quality systems

CGMP ISO knowledge

SOP interpretation

Education

Bachelor's degree in related technical field

Tools

ETQ

Green Light Guru

MasterControl

Veeva

Minitab

Microsoft Office

Job description

Begin your career with us & help bring life-saving medical devices to the market, worldwide

Benefits Include:

• Medical, Dental, Disability & Life Insurance Options – Benefits Start After 30 Days!
• Paid Vacation, Sick Time & Holidays
• On-site Fitness Center, Trainer & Wellness Program – Access for Your Family Too!
• Clean & Temperature Controlled Work Environment
• Shift Differentials
• 401K with Company Match
• Quarterly & Annual Bonuses
• Tuition Reimbursement
• Private, Family Owned Company
• Smaller Company, Less than 500 Employees
• Proudly Based in the USA
• Located Right Off Highway 395

In order to achieve our mission of “Enabling Polymer Technology to Improve the Quality of Life” Putnam Plastics Corporation is focused on building an innovative workforce comprised of employees who pride themselves on challenging the status quo while providing the best quality product to our customers. We strive to provide our employees with the tools to be successful while working in a creative and fun working environment. We firmly believe that each employee contributes directly to our growth and success and that together, we can accomplish great things.

If you are excited by the opportunity to grow with a company that has a distinguished past and an even brighter future, Putnam Plastics Corporation may be the place for you!

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You can view our current open positions below:

Position:Quality Assurance Manager

Location: Dayville, CT

Job Id:247

# of Openings:0

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.
• 40+ years experience across 36 countries
• Innovative design and research expertise
• In-house ISO certified production facilities