Quality & Compliance Manager

Peregrine-Surgical-Ltd; Doylestown (Bucks County); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical – 90% employer paid

Dental – 100% employer paid

Life Insurance & AD&D – 100% employer

Job summary

Dutch Ophthalmic USA seeks a Quality & Compliance Manager to lead the QMS across three US entities, ensuring FDA, ISO 13485 and state regulations compliance. You will serve as US Management Representative, liaising with regulators and driving continuous improvement, audits, and CAPA across the North American sites.

The role requires senior QA leadership, strong regulatory experience, and ability to navigate a multinational team with 25% travel to Exeter & Seabrook, NH.

Qualifications

• Minimum 5 years in a senior role in Quality Assurance in medical device or pharma industry.
• Solid understanding of quality system requirements set by regulatory frameworks for medical devices, such as FDA/ISO 13485.
• Experience managing QA in distribution of devices and pharmaceutical products.
• Ability to translate quality requirements into practical guidance for an organization.
• Experience in managing FDA and/or Notified Body inspections.
• Strong integrity, independence and cross-functional collaboration skills.

Responsibilities

• Set QA and compliance strategy for US sites in collaboration with Global Quality teams.
• Ensure distribution activities comply with applicable federal and state regulations.
• Harmonize QMS across US sites while respecting each site's processes.
• Develop, implement and maintain quality policies and documentation.
• Act as local representative to regulators and manage relationships with authorities.
• Lead field actions, audits, and CAPA processes across North America.

Skills

Quality Assurance

Regulatory Affairs

FDA inspections

Notified Body inspections

Leadership

Communication

Job description

Description

Did you know ...?

Dutch Ophthalmic USA is part of DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.

Every single day our employees ensure that eye surgeons all over the world enjoy the use of innovative ophthalmic devices, instruments, and liquids. DORC uses cutting-edge technology, works closely with innovative surgeons, and thrives to make a difference. Ophthalmologists worldwide use our advanced Ophthalmic surgery unit EVA to take care of their patients to help them see again.

DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.

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.

This role defines and executes the regional quality and compliance strategy, serves as the US Management Representative and primary liaison with regulatory authorities, and ensures that products released to the US market meet all regulatory and quality requirements. The position drives continuous improvement, audit readiness, effective corrective and preventive actions, and provides leadership to the quality team to sustain best-in-class compliance performance.

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 each US site (Exeter, MVI, Peregrine), ensuring compliance with applicable regulatory and QMS requirements.
• Leads and directs the quality teams at each site, serving as the local Head of Quality and ensuring alignment, performance, and effective implementation of quality strategies.
• Ensures communication and aligns priorities between site management and the respective QA team.
• Oversee risk management strategies (tbc).
• This position may require serving as the facility’s Designated Representative for state licensure related to pharmaceutical and medical devices activities and undergoing background checks and fingerprinting as part of the licensure process.

Requirements

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.
• Fluent in English (written and spoken).
• Advanced level in Microsoft Office suite applications.

This is a full-time, fully onsite opportunity. This requires up to 25% travel to Exeter & Seabrook, NH locations, with the remaining time in New Britain, PA.

We have amazing benefits to support you as an employee at Dutch Ophthalmic!

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

Dutch Ophthalmic USA and its subsidiaries provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.