Total Quality Management Senior Manager jobs in New Hampshire

About Sequel

Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

Job Overview

Sequel Med Tech is seeking a highly skilled and experienced Manager, Supplier Quality to lead the development and implementation of our supplier quality management program. Reporting to the VP, Quality, the Manager, Supplier Quality will be responsible for establishing and maintaining robust processes and procedures to ensure that our suppliers, contractors, and service providers meet our quality standards and regulatory requirements.

Job Responsibilities and Essential Duties

· Develop and implement a comprehensive supplier quality management program in alignment with business objectives and regulatory requirements.
· Collaborate with the Supply Chain department to establish and manage an Approved Supplier List, including procedures for supplier qualification and ongoing evaluation.
· Support implementation activities for an ERP system.
· Oversee supplier performance through the analysis of quality data and implementation of continuous improvement initiatives.
· Manage external events and product availability by overseeing contract manufacturer (CMO) production processes through internal batch release.
· Lead investigations and drive timely closure of supplier-related Corrective and Preventive Actions (CAPAs) to address non-conforming materials and services.
· Develop and manage a new vendor management process to streamline operations and improve efficiency.
· Foster strong partnerships with key suppliers, serving as the primary point of contact for quality-related issues. · Completed supplier audits and write audit reports.
· Act as the primary Quality representative for vendor management projects, supporting cost control, inventory management, and compliance initiatives.
· Develop and maintain appropriate controls, processes, and procedures to ensure full compliance with regulatory requirements and industry best practices.
· Communicate effectively with internal stakeholders and external partners, including presenting quality related information and updates as needed.

Minimum Requirements

· Bachelor’s degree in a scientific discipline preferred
· 5 years of progressive experience in quality in a GMP environment, medical device experience strongly preferred
· Ability to work in the Manchester, NH office 2-3 days per week
· Ability to travel nationally and internationally.

Required Knowledge, Skills and Abilities
· Strong understanding of quality management systems and regulatory requirements impacting the medical device industry, including ISO 13485 and FDA regulations
· Excellent written, verbal, and presentation skills
· Proven ability to develop and implement quality programs and systems
· Demonstrated experience in supplier management and continuous improvement initiatives
· Strong analytical and problem-solving skills
· Ability to work in a fast-paced, ambiguous startup environment

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Environmental/Safety/Physical Work Conditions
· Ensures environmental consciousness and safe practices are exhibited in decisions
· Use of computer and telephone equipment and other related office accessories/devices to complete assignments
· May work extended hours during peak business cycles
· Physical requirements such as lifting specific weights
· Travelling is expected