Documentation Control Specialist - Manchester, United States - Sequel Medical Technology

Sequel Medical Technology Manchester, United States

1 week ago

Description

Job Description

Job DescriptionAbout Sequel

Sequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions. Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare.

Job Overview

The Documentation Control Specialist will be a key member of our growing Quality/Regulatory team as we build out a robust OMS compliant system with FDA and EU regulations. The Documentation Control Specialist will be key player supporting the Document Control Manager with implementing Sequel's QMS, MLR process review and approvals, and document control system implementation. The Documentation Control Specialist will provide documentation support to all areas of quality, regulatory and external manufacturing.

Job Responsibilities and Essential Duties

Manage and maintain the full life cycle of all controlled documents in the quality management system including document creation, obsolescence, archival, and revisions.
Review documents for accuracy, completeness, and compliance in accordance with relevant regulations (e.g., ISO 13485, FDA CFR 820).
Assist with the management and maintain Medical, Legal, and Regulatory (MLR) review and approval processes with a QMS associated with advertising, promotional, and training materials. Including maintaining a matrix of obligations that change across multiple jurisdictions. for multiple products, with auditable records that show compliance with applicable requirements.
Develop and maintain documentation templates within the OMS and project databases and maintain hard copy records when required.
Maintain site compliance with good documentation practices and cGxP data integrity requirements.
Partners with functional areas to conduct periodic reviews of existing procedures.
Responsible for tracking batch records, logbooks, and other controlled forms/documents.
Drive and facilitate change management.
Foster a collaborative and inclusive team culture of quality engineers that values diversity and promotes innovation, and develops succession plans, skills assessments, and training .

Minimum Requirements

Associate degree in Computer Science, Information Systems, Business Administration, preferred or 3-years Documentation Control related field experience.
Veeva Vault, Veeva Learning, Veeva QMS, Veeva PromoMats preferred.
Minimum of 3 years of experience Veeva Modular(s) or similar role.

Required Knowledge, Skills and Abilities

Strong understanding Quality Management systems and Regulatory requirements impacting the medical device industry, including ISO 13485 and FDA regulations.
Excellent written, verbal, and presentation skills.
Proven ability to develop and implement quality programs and systems.
Demonstrated experience in Document Control and continuous improvements initiatives.
Strong problem-solving skills.
Ability to multitask in a fast-paced ambiguous startup environment.

Sequel Med Tech provides 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.

Environmental/Safety/Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions
Use of computer and telephone equipment and other related office accessories/devices to complete assignments
May work extended hours during peak business cycles
Physical requirements such as lifting specific weights
Some travelling may be expected

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