Description JOB SUMMARY: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.
KEY RESPONSIBILITIES:Full QMS Ownership (Strategy + Execution) - 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.
- Hands-On Quality Operations.
- 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.
Regulatory & Audit Leadership - 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.
Organizational Influence & Strategic Partnership - 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.
Position Requirements KNOWLEDGE/SKILLS/ABILITIES REQUIRED - 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.
- Knowledge of 21 CFR 803 and 806 is preferred; MDSAP experience is a plus.
- 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.
PHYSICAL DEMANDS: While performing the duties of this role, the employee is:
- Constantly required to reach, use computers, and operate standard office equipment.
- Constantly required to view objects at both close and distant ranges.
- Constantly required to communicate effectively with others.
- Frequently required to sit and stand.
- Occasionally required to lift and transport items weighing up to 30 lbs.
This position functions in both office and technical environments, requiring fine motor skills and manual dexterity to operate computers and standard office equipment (telephone, fax, copier, etc.).
Equipment typically used: Computers, Heidelberg devices, USB drives, MO disks/drives.
Note: "Occasionally" = up to 1/3 of the workday, "Frequently" = 1/3-2/3, and "Constantly" = more than 2/3.
WORK ENVIRONMENT: The employee frequently works in a professional office environment with extensive computer equipment and moderate levels of noise and activity. Occasional travel to GmbH headquarters may be required. The work environment is fast-paced and demanding. This is a full-time, on-site role based in the Franklin, MA office.
Salary Range: $95,000 - $130,000
Full-Time/Part-Time Full-Time
Number of Openings 1
Location HQ - Franklin, MA
This position is currently accepting applications. 
