Quality and Compliance Manager

What is the role?

As Quality & Compliance Manager, you will be responsible for leading and overseeing the Quality Management System (QMS) across three US entities, ensuring harmonization while maintaining compliance with FDA, ISO 13485, and applicable federal and state regulations governing medical device and pharmaceutical distribution activities.

Responsibilities

• Set the organizational and compliance strategy for the QA organization in the US in collaboration with the Zeiss Global Quality team.
• Ensures that the commercial and distribution activities are conducted per a QMS that ensure compliance to federal and state regulations for devices and pharmaceutical products.
• Manage and harmonize the QMS across the three US sites while respecting each site’s unique processes.
• Develop, implement and maintain quality policies and documentation.
• Acts as the local representative of DORC for regulators in North America on Quality and Compliance topics.
• Accountable for verification that DORC products that are released for distribution on the US market meet specifications and regulatory requirements such as ISO13485 or FDA regulations.
• Accountable for timely and effective executing and reporting of field corrective actions in North America.
• Executes management oversight on all locations in North America where DORC carries responsibility for FDA regulated activities.
• Reports to HQ on the effectiveness and level of compliance in DORC sites in North America through management review and other management oversight meetings.
• Drives continuous improvement of QMS governed processes aimed at increasing efficiency, effectiveness, harmonization and compliance.
• Prepare for and host external audits at DORC sites in North America and drive resolution of associate non-conformities.
• Address non-conformities and implement corrective actions.
• Educate, train and advise the organization on quality and compliance matters.
• Initiate improvement projects & initiatives.
• Timely escalation and resolution of quality or compliance concerns.
• Act as Management Representative for US.
• Lead, direct and train the quality team members.
• Oversee risk management strategies (tbc).

Skills, know-how and experience

• Minimum 5 years in a senior role in Quality Assurance in medical device or pharma industry.
• Solid understanding of quality system requirements set by the major regulatory frameworks for medical devices and combination products.
• Relevant experience in managing and overseeing quality aspects in distribution, preferably in disposable devices as well as pharmaceutical products.
• Ability to effectively translate quality requirements into practical directions for the organization.
• Experience in management of FDA and/or Notified Body inspections.
• High level of integrity and ethical standards.
• Ability to multi-task and methodically manage projects based on business priorities and resource availability.
• Ability to self-motivate and work independently in a geographically separated multi-national and multi-functional team environment.
• Collaborates effectively across a diverse network.
• Open-minded for improvement opportunities and change towards striving for best-in-class compliance performance.
• Ability to think creatively, proactively identifying alternative solutions to problems.
• Experience in people management.
• Effective communication/interpersonal skills.
• Fully fluent in English (written and spoken).
• Advanced level in Microsoft Office suite applications.

Benefits

• Medical – 90% employer paid
• Dental – 100% employer paid
• Lifetime Life Insurance, AD&D, STD & LTD Insurance – 100% employer paid
• Vision – 100% employer paid
• 401k Matching
• Paid Leave: Sick, Vacation and Holidays

Full-time, fully onsite opportunity

The role requires up to 25% travel to New Britain, PA, with the remaining time divided between the Exeter & Seabrook, NH locations.