Quality Assurance Manager

Putnam Plastics; Dayville (CT); On-site; USD 110,000 - 150,000; Full time

Job summary

Putnam Plastics is seeking a QA/RA Manager to oversee the quality management system and the QA/RA team. You will review procedures, lead internal and supplier audits, and drive continuous improvement to meet GMP and ISO 13485 requirements.

You will collaborate with cross-functional teams, ensure regulatory compliance, maintain documentation, and support customer inspections and change control processes.

Qualifications

• Bachelor’s degree in related technical or administrative field.
• 10+ years of supervisory experience in a regulated setting.
• 5 years in a regulated manufacturing organization.
• Strong knowledge of ISO 13485 and QMS practices.
• Experience with material compliance and regulatory standards.
• Experience establishing and maintaining a QMS with document control, change control, audits, CAPA and complaint handling.
• Proficient in MS Office; ERP/PLM/PDM familiarity.
• Demonstrated leadership and cross-functional collaboration.
• Strong analytical and communication skills.

Responsibilities

• Oversee and maintain the Quality Management System (QMS).
• Lead QA/RA team and ensure regulatory compliance across functions.
• Coordinate internal and external audits and customer inspections.
• Drive continuous improvement and cross-functional collaboration.
• Manage document control, change control and CAPA processes.

Skills

ISO 13485

QMS leadership

Regulatory compliance

CAPA & audits

eQMS knowledge

ERP/PLM familiarity

Regulatory standards

Document control

Analytical thinking

Communication skills

Education

Bachelor’s degree

Tools

eQMS software

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,

Summary:

The Quality Assurance & Regulatory Affairs (QA/RA) Manager is primarily involved in the general oversight and maintenance of the quality management system (QMS) and quality engineering team. This would include, and is not limited to, review and approval of procedures, oversight of all auditing activity, dedication to ongoing improvements and performance enhancements across the business. Includes cross-functional team participation

• Work with the Head of Quality & Regulatory Affairs to maintain the department goals.
• Model continuous professional and communicative behavior.
• Participate productively and cohesively in internal and customer meetings, site visits and inspections as they occur.
• Work closely with peers to maintain cohesion amongst the departments and overall business.
• Independently manage competing priorities, allocates and assigns resources to meet target and timelines.
• Actively lead a multi-functional team.
• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Maintain programs and processes to ensure high-quality products and compliance with current GMPs and ISO standards.
• Assist in creating and maintaining a culture of quality and accountability among all employees to meet and exceed customer expectations.
• Provide leadership to set standards and expectations that promote teamwork, trust, ownership, excellence, creativity, innovation, and growth.
• Provide support and participate in IT projects to ensure deployments of systems meet relevant regulations, and that systems are maintained in a validated state (e.g., eQMS, PDM, ERPs systems, etc.).
• Monitor and report quality and compliance-related commitments.
• Supports general corporate operations by managing projects assigned in accordance with overall company and quality objectives.
• Develops and provides quality metrics and trend analysis reports for functions and leadership on a regular and as needed basis.
• Quality Management System (QMS):
• Thoughtfully apply ISO 13485 to the QMS and business practices.
• Oversee, maintain and improve the QMS by reviewing and developing processes, while including feedback from internal stakeholders and process owners.
• Maintain the function and development of the eQMS.
• Author, review and approve controlled documents.
• Own the change control process to support the continuous improvement of operational or quality processes via a formalized process and any subsequent customer notifications.
• Coordinate and communicate activities within the management/supervisory team.
• Coordinates and communicates process, product, and operational continuous improvement priorities within the department so those involved in Doc Control, CF’s, Training and Compliance are corporately aware of cross functional needs.
• Assist in the implementation and further development of quality and regulatory policies and procedures, in alignment with business objectives.
• Material Compliance, CAPAs, NCs, Feedback & Complaints:
• Manage customer and supplier requests for information, including but not limited to material compliance.
• Directly maintain and develop the CAPA, NC and complaint systems.
• Continuously teach and guide using techniques and methods for process improvements, efficiency, thorough investigations and root cause analysis.
• Thoroughly document quality events and remediation measures as they occur.
• Audits:
• Oversee all audit activities and tracks compliance.
• Lead internal and external audits, customer inspections, or any regulatory authority inspections as needed.
• Actively participate in managing suppliers by assessing their performance.
• Training:
• Oversee the maintenance and general activities of the training program.
• Responsible for creating and monitoring content for quality and regulatory‑related employee training.
• Ensure appropriate support is provided to all departments for an effective training program efficiently and effectively to conduct direct responsibilities in their assigned roles.
• Partners with subject matter experts (SMEs) and key stakeholders to identify training needs.
• Assist in the development and maintenance of training content, training curricula, and metrics.
• Provides coaching and/or training to co‑workers cross training.
• Train employees directly, when appropriate.
• Management Responsibilities:
• Actively supports and cultivates PPC core values of Honesty, Respect, Dedication, and Innovation. As well as Safety 1 st in the workplace.
• Provides clear written and verbal instructions to groups and promptly addresses any team member’s questions or concerns.
• Works with Supervision, Management and HR in order to assist with an efficient workflow and environment setting. Communicates with management all appropriate concerns related to working conditions, safety, injuries, and interpersonal conflicts in a timely manner.
• Provides feedback and information to identify any potential barriers/issues/concerns.
• Actively supports a culture of continuous improvement. Offers and supports ideas for improvement.
• Reviews documentation for accuracy, educates and corrects, accordingly.
• Efficiently delegates tasks, encouraging teamwork while assigning responsibilities to team members. Clearly outlines goals, ensuring group members understand what’s expected of them.
• Follows policies, practices and procedures, as well as assist employees by conveying knowledge of the same or referring them to Management or HR.
• Actively works with HR regarding employee relations:
• Interviews, hires, terminations, coaches, disciplinary actions and the like.
• Develop employees for future advancement, where applicable. Assist with employee retention.
• Provides timely and appropriate formal and informal job performance feedback to direct reports, this includes reviews and warnings, and the like.
• Responsible for employees’ timecards, accurate inputting into Paycor, approving/declining sick/vacation time, and the like.

Required Qualifications:

Bachelor’s degree in related technical or administrative field.

• 10+ years of previous supervisory experience.
• 5 years’ experience in a regulated manufacturing organization.
• Strong working knowledge of medical device manufacturing quality management systems (ISO 13485).
• Knowledge of material compliance and regulatory standards such as REACH, RoHS, Conflict Minerals, Prop 65, Material Declarations.
• Demonstrated ability to establish and maintain a successful QMS with working knowledge in areas such as document management, change control, audits, corrective and preventative action (CAPA), and complaint handling.
• Demonstrated attention to detail, accuracy and organization.
• Self‑reliant in determining priorities and setting schedules to meet goals and objectives.
• Strong analytical and critical thinking skills. Able to collect, interpret, organize, and communicate data.
• Computer: Prior experience with electronic quality management systems (eQMS) such as ETQ, CEBOS, Green Light Guru, Master Control, Qualio, 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.
• Familiar with modern ERP systems, PLM systems, PDM, Agile, etc.
• Able to work within a team and as an individual contributor in a fast‑paced, changing environment including the ability to leverage and/or engage others to accomplish projects.
• Demonstrated team building and empathic leadership skills.
• Strong interpersonal skills, verbal and written communications with ability to effectively communicate at multiple levels in the organization.