Quality Manager

ENNOVI; Attleboro (MA); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Ennovi Medical seeks a Quality Manager to own the development and implementation of the quality system across ISO9001, IATF16949, and ISO13485. You will be the Management Representative and lead validation efforts, audits, and continuous improvement initiatives.

You will manage a quality team, drive internal and supplier audits, and collaborate with customers to ensure compliance and product quality. Join Ennovi’s mission to deliver safer, smarter medical solutions.

Qualifications

• Bachelor of Arts or Science Degree or Higher.
• Automotive manufacturing experience including AIAG core tools, LPA’s and RFMEA’s.
• Six sigma black belt and lean experience / certification preferred.

Responsabilités

• Develop, document, implement and register Quality Systems for ISO9001, IATF16949 and ISO13485.
• Lead medical validation activities (IQ, OQ and PQ) per ISO 13485.
• Provide procedural and policy guidance related to quality systems and initiatives.
• Conduct training and monitoring to ensure adherence to quality standards and procedures.
• Manage and supervise the Quality staff in daily responsibilities.
• Champion the internal audit system and customer audits (e.g., VDA6.3).
• Develop metrics tracking and reporting for manufacturing and process quality.
• Lead MRB committee to disposition non-conformances and initiate corrective actions.
• Coordinate document control activities as required by standards.
• Monitor monthly and annual quality improvement goals for Ennovi corporate.

Connaissances

Quality systems

Leadership

Training

Formation

Bachelor's degree or higher

Outils

AIAG core tools

LPA’s

RFMEA’s

Description du poste

At Ennovi we harness the power of two megatrends - electrification and AI - to help industries innovate at speed, operate smarter, and achieve sustainable growth. By combining these transformative forces with our global reach and best talent, we empower our customers to lead their markets and drive sustainable progress. From automotive and aerospace to consumer electronics, data storage, industrial, and medical markets, we harness these forces to help our customers create smarter, safer, and more sustainable solutions.

At Ennovi Medical, we serve as an end-to-end customized solution partner, empowering OEMs to harness AI-driven technologies and accelerate innovation for medical devices.

At the crossroads of experience and innovation, we create out-of-the-box enabling technologies within the highly regulated medical business sector. We maintain ISO 13485 certification and FDA registration in Design Control and as a contract manufacturer. Ennovi Medical partners with clients at the earliest stages of the product development process–including voice-of-the-customer research in a clinical setting–to develop the product input document for our client’s medical device. Ennovi Medical business has 4 sites globally and 3 R&D Centers. Learn more at www.ennovi.com/medical/

Ennovi is an equal opportunity employer in conformance with all applicable laws and regulations to individuals who are qualified to perform job requirements. The Company administers its personnel policies, programs, and practices in a non-discriminatory manner in all aspects of the employment relationship, including recruitment, hiring, work assignment, promotion, transfer, termination, wage and salary administration, and selection for training.

Why Join Us

We offer a dynamic, collaborative and inclusive culture that encourages continuous learning, professional growth, and a sense of purpose. As a part of the Ennovi team, employees experience the excitement of being at the forefront of cutting-edge technologies and contributing to a sustainable future.

Our commitment to the transformation is epitomized by our five pillars: Speed, Innovation, Best Talent, Global Reach, and Sustainability. This entails navigating exponential market changes through agile structures, fostering innovation across all aspects of our business, strategically expanding our global footprint, championing sustainability initiatives and nurturing a winning team.

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Job Summary

Responsible for all aspects of the development and implementation of the quality system including preventive and corrective actions, non-conformance control, and continuous improvement and quality system effectiveness. Provides a single point of contact for those projects to the General Manager and President.

Main Responsibilities

• The Quality Manager is responsible for the development, documentation, implementation and registration of the Quality Systems for ISO9001, IATF16949 and ISO13485. This position is the Management Representative as defined in ISO9001, IATF16949 and ISO 13485.
• Leads medical validation efforts including IQ, OQ and PQ activities in accordance with ISO 13485 standards
• Provide procedural, strategic and policy guidance in written and verbal form related to the quality systems and assigned other assigned initiatives. Reviews and maintains quality systems to assure continued compliance.
• Conduct training and monitoring activities to ensure adherence to quality standards and procedures by employees and suppliers. Maintains and enforces authority for self and all members of organization the ability to stop production due to quality requirements.
• Manage and supervise the Quality staff in the execution of daily responsibilities.
• Champion the internal audit system including the selection and training of internal auditors. Experienced in customer audits, specifically VDA6.3.
• Develop performance metrics tracking and reporting system for manufacturing and business process quality.
• Champions customer quality and champions Company’s needs from customers for documentation and information to support the development of customer requirements. Develops a working relationship with customers to understand their current and projected requirements for quality of products and services.
• Lead MRB committee to quickly disposition non-conformances. Initiate corrective action requests as required.
• Coordinates and administers document control activities as required by the standard.
• Set, monitor and report on the status of monthly and annual quality improvement goals to support Ennovi corporate requirements.
• Leads ISO14001 registration process and necessary environmental controls.

Qualifications

• Bachelor of Arts or Science Degree or Higher, and job-related experience, including strong experience and background of quality systems and their mechanics in a medical and automotive manufacturing environment.
• Automotive manufacturing experience required including competency in AIAG core tools, LPA’s and RFMEA’s.
• Six sigma black belt and lean experience / certification preferred.