Quality and Compliance Manager

ZEISS Group•Seabrook, NH

1d•Onsite

About The Position

Dutch Ophthalmic USA and 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. The Quality and Compliance Manager provides strategic and operational quality and compliance leadership across three (3) US entities: MicroVision Inc, Dutch Ophthalmic US and Peregrine Surgical. This role serves as the primary liaison between U.S. Quality teams and Global Quality, ensuring alignment with quality and compliance standards, regulatory requirements, and company objectives.

Requirements

Minimum Bachelor degree in a relevant field of engineering.
Qualification in Quality Assurance (e.g. six-sigma, lean, ASQ).
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.
Up to 25% travel across three sites, Exeter & Seabrook, NH & New Britain, PA.

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).
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.