Sr. Manager, Quality Systems

Getinge•Merrimack, NH

3d•$160,000 - $180,000•Hybrid

About The Position

This role provides hands-on quality and compliance leadership across the Compliance, Corrective & Preventative Action, and Training departments while supporting, regulation changes and Regulatory Audits. Responsible for ownership, oversight, and continuous improvement of the Quality Management System and for ensuring compliance of our products and operations. The Sr. Manager of Quality Systems and Compliance is a quality decision maker, escalation point and system owner, typically bringing 5-10 years of knowledge and experience in the regulated medical device environment. This role will interact cross-functional departments (production, maintenance, engineering, regulatory etc.) as well as with support personnel, and other external parties on issues related to quality. This high influence position will interface with employees at all levels and various functions / departments across the business and within the facility.

Requirements

Bachelor’s degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience (master’s preferred)
5-10 years’ experience in the FDA regulated environment (Medical Device preferred).
Experience in Quality in an FDA regulated industry.
Strong experience with FDA and ISO regulations and standards
Experience with Audits, CAPA systems and training systems
Successful experience in factory level quality, engineering, compliance and training management.
Good analytical and problem-solving skills.
High level of attention to detail and accuracy.
Leadership and mentoring skills.
Effective verbal and excellent technical writing skills.
Excels at generating and maintaining organized and accurate records.
Able to make effective decisions quickly based on vague or imperfect information.
Ability to create and maintain professional relationships within all levels of the organization (peers, work groups, management).
Ability to work independently and as a member of a team.
Flexibility to operate and self-driven to excel in a fast-paced environment.
Capable of multi-tasking, highly organized, with excellent time management skills.

Responsibilities

Improve and maintain a compliant Quality Management System and team that contributes to outstanding customer service and promotes the highest standards for product quality.
Develop and/or manage quality and compliance to enable the tools and processes that support an operational excellence environment and ensure compliance with all company and audit requirements.
Establish and maintain key quality KPI’s and score cards/tracking mechanisms to ensure continuous improvement.
Manage existing and create new, if necessary, quality processes that increase efficiency while maintaining compliance and control.
Ensure plant policies and procedures are following all FDA and Country regulations.
Plan, conduct and respond to internal and regulatory bodies regarding audits and inspection requests.
Serve as a technical expert for Audit/Inspections for your respective departments.
Monitor, trend and report QMS and regulatory compliance metrics for Management Review and Monthly Quality Meetings
Support/lead all quality and regulatory inspections and audits, as well as the completion of all action items in a timely manner.
Support the development and implementation of training programs and best practices required to maintain high quality standards.
Lead technical teams to efficiently implement system improvements across multiple departments.
Work with site management to create timelines, create progress reports, and manage all program elements including proactive communications regarding initiatives
Provide mentoring and guidance to Quality Systems and Compliance personnel
Contributes to the team effort by accomplishing related tasks as necessary.