Quality Lead

Heidelberg Engineering•Franklin, MA

8h•Onsite

About The Position

Heidelberg Engineering is seeking an experienced, hands-on Quality Lead to lead and own the company's Quality Management System (QMS) within a regulated medical device environment and establish annual management reviews. The successful candidate will maintain and ensure compliance of site-specific QMS processes aligned with global QM while actively driving continuous improvement, regulatory readiness, and a culture of quality across the organization. This position offers a unique opportunity to directly influence compliance strategy, operational excellence, and the future growth of the Quality function. The successful candidate will closely collaborate with the HE Headquarters in Germany and establish a quality reporting.

Requirements

Bachelor's degree or equivalent combination of education and work experience.
Minimum of 5+ years of progressive experience in medical device quality management.
Demonstrated expertise in ISO 13485, FDA 21 CFR Part 820, GMP, and regulatory inspection readiness.
Track record of operating independently in a sole-leadership quality role.
Strong hands-on execution capability combined with strategic thinking and leadership presence.
Experience leading audits, regulatory interactions, and executive reporting.
Exceptional analytical, organizational, and problem-solving skills.
Excellent communication skills with the ability to influence across all organizational levels.
Comfortable building structure, strengthening systems, and developing scalable quality processes.

Nice To Haves

Knowledge of 21 CFR 803 and 806 is preferred
MDSAP experience is a plus.

Responsibilities

Own, maintain, and continuously improve the Quality Management System to ensure regulatory compliance and operational effectiveness.
Balance strategic oversight with daily hands-on execution of quality activities.
Identify systemic risks and gaps, implement corrective strategies, and strengthen compliance infrastructure.
Develop quality objectives aligned with business goals and corporate standards.
Support complaint handling and investigations in coordination with global HQ.
Escalate and support MDR/reportability decisions.
Maintain and administer document control, change management, and training systems.
Support risk management activities across the product lifecycle.
Analyze field performance trends and implement preventive and corrective actions.
Serve as the primary on-site liaison during FDA inspections in coordination with global regulatory teams.
Prepare for, host, and respond to regulatory inspections and external audits.
Conduct and facilitate Management Review meetings, providing executive-level quality performance reporting.
Support post-market surveillance, regulatory reporting, corrections, removals, and recall strategy development.
Act as a trusted advisor to senior leadership on regulatory risk, compliance strategy, and quality performance.
Drive cross-functional accountability for regulatory compliance and continuous improvement.
Promote a strong quality culture across all departments.
Build scalable systems and processes to support future growth of the Quality function.