Onsite Quality Manager in Romulus

Job DescriptionJob Description

Position Summary

The Quality Manager is responsible for the daily operational execution and administration of the Quality Management System (QMS) within the manufacturing environment. This role serves as the primary onsite quality leader responsible for ensuring compliance with FDA, ISO 13485, EU MDR, and internal quality requirements through direct engagement with production, suppliers, audits, and quality system processes.

The Quality Manager serves as the operational owner of quality activities and is responsible for maintaining audit readiness and ensuring effective implementation of quality processes across the organization.

Key Responsibilities

Operational Quality Management

·        Manage daily quality system operations within the manufacturing environment.

·        Ensure ongoing compliance with applicable regulatory and quality requirements

·        Support production operations through direct interaction with manufacturing personnel.

·        Escalating quality and compliance risks informing executive management as appropriate.

Audit Management

·        Prepare for and host all onsite audits and inspections including:

·        FDA inspections

·        ISO 13485 audits

·        EU MDR audits

·        Customer audits

·        Supplier audits

·        Coordinate audit logistics, documentation, and personnel preparation

·        Lead audit response and corrective actions activities.

Document & Change Control

·        Coordinate Document Change Request (DCRs) and Engineering Change activities.

·        Ensure changes are processed in accordance with established procedures and regulatory requirements.

·        Maintain controlled documentation systems.

Device History Record (DHR) & Production Quality Coordination

·        Coordinate Device History Record (DHR) review activities

·        Ensure production records are complete, accurate, and compliant and align with Device Master Record (DMR) requirements.

·        Work directly with operations personnel to resolve documentation and quality issues.

CAPA Management

·        Coordinate and monitor CAPA activities.

·        Ensure investigations, root cause analysis, corrective actions, preventive actions, and effectiveness checks are completed timely.

·        Track quality system metrics and trends.

Training Management

·        Coordinate employee training and training record maintenance.  

·        Ensure personnel are trained to applicable procedures and regulatory requirements.

·        Support training effectiveness initiatives.

Supplier Quality Management

·        Manage Supplier Quality programs and supplier performance activities.

·        Coordinate supplier evaluations, monitoring, and issue resolution.

·        Lead supplier issued escalation activities and corrective action follow-up.

Personnel Supervisor

·        Supervise onsite Quality personnel.

·        Assign responsibilities and monitor departmental workload.

·        Support employee development and performance management.

Continuous Improvement

·        Drive operational quality improvements and quality culture initiatives.

·        Support process improvement and compliance enhancement activities.

·        Participate in management review and quality planning activities.

·        Act in compliance with Employee Handbook.

·        Promote company values and ethics.

Skills / Abilities

· Strong leadership, organizational, and communication skills.

· Ability to interact effectively with various departments within the organization and with external parties.

· Experience and demonstrated knowledge of Quality Management System requirements with FDA 21 CFR Part 820/QMSR, ISO 13485, and MDR 2017/745. Ability to reference other international Quality and Regulatory Standards as required.

· Experience in addressing customer complaints, and CAPA systems in a medical device environment.

· Competence in performing effective troubleshooting. Excellent problem-solving skills (root cause analysis).

· Prior experience interpreting technical drawings & specifications.

· Proficient in the use of measuring and testing equipment.

· Experience in the use of PC’s and Microsoft Office software applications required.

Qualifications

· Bachelor’s degree in engineering, Quality, Life Sciences or related technical discipline is . Equivalent

experience and training in the Quality profession, i.e. ASQC certification programs and MDR2017-745 are

equivalent requirement considerations.

· Minimum of 5 years of Quality Management experience in regulated medical device manufacturing

environment.

· Experience hosting FDA, ISO 13485, and/or MDR audits strongly .

Work Environment

Office environment with regular exposure to production areas. The position will require wearing common

protective or safety equipment as designated by company policy. The position may require standing or sitting

for extended periods of time. Occasional travel to customers and suppliers as needed.

Company DescriptionSynchronis Medical is a design, development and contract packaging and manufacturing firm located in Romulus, MI. Our ISO 13485 accredited Quality Management System has given customers around the world, the confidence that our goods and services will be done right, with precision and professionalism.

Synchronis Medical has a dedicated kit-packing division, building specialty kits for civilian and military consumption around the world. Manufacturing is done in our class 8 clean room, on a form, fill and sealing machine, with state of the art in-line printing capabilities.

Senior leadership has over 100 years of combined medical device experience, ranging from class 1 products to Premarket Approved Devices. We have patents and IP around products that are utilized by every military on the planet, including the Halo Seal and Halo Vent Chest Seals.

We’ve earned our stellar reputation through hard work, ethical practices, and years of clinical and practical experience, to help our customers solve their product needs.Company DescriptionSynchronis Medical is a design, development and contract packaging and manufacturing firm located in Romulus, MI. Our ISO 13485 accredited Quality Management System has given customers around the world, the confidence that our goods and services will be done right, with precision and professionalism.\r\n\r\nSynchronis Medical has a dedicated kit-packing division, building specialty kits for civilian and military consumption around the world. Manufacturing is done in our class 8 clean room, on a form, fill and sealing machine, with state of the art in-line printing capabilities.\r\n\r\nSenior leadership has over 100 years of combined medical device experience, ranging from class 1 products to Premarket Approved Devices. We have patents and IP around products that are utilized by every military on the planet, including the Halo Seal and Halo Vent Chest Seals.\r\n\r\nWe’ve earned our stellar reputation through hard work, ethical practices, and years of clinical and practical experience, to help our customers solve their product needs.