Senior Manager, Quality Digital Product Software

ZipRecruiter; Manchester; On-site; GBP 80,000 - 100,000; Full time

Job description

About Sequel
Sequel Med Tech is an early-stage company developing the next of precision drug delivery devices.

Job Overview

We are looking for an experienced Senior Manager, Quality Digital Product Software to lead quality efforts for the development and distribution of software products, including design and development as required and validation and verification efforts for the software components of Sequel’s digital products. This role will ensure compliance with FDA regulations and industry best practices, oversee quality approvals, and support product release. The ideal candidate will be a subject matter expert (SME) in software product development within a highly regulated environment.

Job Responsibilities and Essential Duties

• Lead software validation and verification efforts to ensure compliance with FDA regulations and industry (e.g., 21 CFR Part 11, IEC 62304, ISO 13485).
• Own the quality approval process for software components, including documentation review and final release approvals.
• Act as the SME and work with the software product team to maintain, refine and improve the processes (policies, SOPs, supporting documentation) for this area of the quality system.
• Work closely with the software engineering team to implement and maintain a robust software quality management system.
• Follow agile practices in the development of medical software products, including TIR45, PCCP, or other models for agile software compliance.
• Communicate project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks.
• Develop and support the teams that execute validation protocols, test scripts, and traceability matrices to ensure software functionality, reliability, and regulatory compliance.
• Provide expertise in risk management and design controls for software as part of a medical device (SaMD) and embedded software components.
• Lead internal and external quality audits and investigations related to software validation and compliance.
• Collaborate with cross-functional teams, including regulatory, engineering, and operations, to support overall product lifecycle management.
• Support QA department to determine document needs, establish, and improve necessary document templates, and guide staff to support project needs and maintain site compliance with good documentation practices and cGxP data integrity requirements.
• Stay up-to-date with evolving FDA, ISO, and other regulatory requirements for product software quality and validation.

Minimum Requirements

• B.S. or equivalent in computer science, engineering, life science, or related field.
• 7+ years of experience in software quality assurance in the life sciences industry.
• Previous experience in a leadership role.

Required Knowledge, Skills and Abilities

• Previous experience supporting product software development and commercialization with a medical device company.
• Working knowledge of related QMS, regulations (e.g., 21 CFR Part 11, IEC 62304, ISO 13485).
• Understanding of software development methodologies and concepts.
• Strong oral and written communication skills in English.
• Advanced proficiency in the use of MS Office suite.
• Working knowledge of Microsoft Project and basic project management skills.
• Strong skills at team facilitation, team organization, communication of priorities, and listening.
• Excellent interpersonal skills; open to creative, innovative, flexible, and practical approaches to improving practices and solving problems.

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 traveling is expected.