Design Control Process Manager

For our client, a leader in the healthcare space, we are seeking a Design Control Process Manager to lead operational priorities where safety, quality, compliance, and execution discipline are central to success.

About the role

You will collaborate with field leadership, support functions, and cross-functional stakeholders to improve accountability, service delivery, and operational consistency. The position offers the opportunity to influence operational scale, customer outcomes, and organizational performance within a healthcare environment.

Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Develop and improve design control processes governing medical device development
• Ensure integration of design control processes with FDA and ISO compliance
• Translate regulatory requirements into practical procedures and tools
• Evaluate design control effectiveness and recommend updates based on quality data
• Create implementation plans for new design control requirements across projects
• Establish processes for accurate and audit-ready Design History Files
• Manage quality assurance methods for product design and development

Qualifications

• BS in Engineering or related technical discipline
• 12+ years of experience in medical device Quality Assurance or Design Assurance
• Expertise with FDA 21 CFR 820, 21 CFR Part 11, ISO 13485, and ISO 14971
• Familiarity with IEC 60601, IEC 62366, and IEC 62304 standards
• Proficiency in QMS software (e.g., MasterControl, Veeva Vault) and Document Control systems
• Strong cross-functional influence and adherence capabilities
• Proven ability to collaborate with Quality, Regulatory, R&D, and Manufacturing teams

Pay

$151,000 – $196,000 annually

Benefits

• Remote work opportunities
• Collaborative work environment with cross-functional teams
• Opportunities for professional growth and development
• Involvement in impactful medical device innovation
• Supportive culture for quality and regulatory excellence