Design Control Lead
Hired by Matrix, Inc.
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Job Details
Skills
- DESIGN CONTROL LEAD
Summary
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Design Control Lead.
Position Type:
- Contract
- Remote
- 8+ years of experience in medical device design controls within a regulated environment.
- Demonstrated experience leading design control remediation initiatives, particularly in response to regulatory findings or compliance gaps.
- Deep knowledge of medical device quality and regulatory standards, including FDA QMSR, ISO 13485:2016, and design control requirements.
- Strong expertise in ISO 14971 risk management, including integration of risk management activities into design controls and product lifecycle processes.
- Proven experience integrating design controls, risk management, and post-market inputs across complex product systems or product platforms.
- Experience supporting regulatory inspections, audits, and remediation programs, including regulator-facing documentation and responses.
- Strong leadership, communication, and stakeholder management skills, with the ability to influence cross-functional teams and senior leadership.
- Serve as Design Control Remediation Sub-Workstream Lead, providing technical direction, escalation management, and decision support for Design History File (DHF) remediation activities.
- Lead execution of design control remediation activities, ensuring alignment with remediation plans, procedures, and program objectives.
- Own and manage CAPAs related to design control observations, ensuring corrective actions are effectively implemented and sustained.
- Oversee cross-functional teams executing remediation workstreams, ensuring deliverables, timelines, and quality standards are met.
- Ensure effective integration between design controls and risk management, collaborating closely with risk management workstream leadership.
- Evaluate and remediate the application of ISO 14971 risk management principles across design control processes and deliverables.
- Support regulatory readiness, including preparation for audits and inspections, and ensure remediation documentation is robust, defensible, and inspection-ready.
We want to hear from you! If you think you''d be a good match, submit your resume and reach out to Shaan at to learn more.
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- Dice Id: mic
- Position Id: 26-01006
- Posted 3 hours ago
Company Info
About Hired by Matrix, Inc.
Hired by Matrix is a leading staffing organization providing exceptional contingent and permanent staffing solutions to clients across the United States. At Hired by Matrix, we believe in the human touch and start every partnership with an in-depth conversation. By talking with our clients about their hiring needs and listening to job seekers describe their career goals, we build an understanding of what they are looking for and work hard to make it happen. Further, as a proud member of the Women’s Business Enterprise National Council (WBENC), we strive for excellence in diversity and inclusion.
Our staffing services encompass a wide range of industries and professions:
· Travel Nursing: We excel in connecting healthcare facilities with highly skills Travel Registered Nurses for bedside care on short-term engagements as well placing professional allied health staff.
· Information Technologies: We provide businesses with proficient IT Professionals who possess expertise in various technologies and programming languages.
· Engineering: We have a team specialized in recruiting talented engineers for diverse industries such as civil, mechanical, electrical, manufacturing and more.
· Human Resources: Our comprehensive HR staffing solutions help companies find to HR professional with extensive knowledge in recruitment, employee relations and HR Management.
· Life Science: We assist companies in the pharmaceutical, biotechnology, and medical device sectors by sourcing scientific and research professionals with specialized expertise
· Finance & Accounting: We provide finance and accounting professionals to organizations, including CFO’s, Accountants, financial analysts, and more.
· Administrative & Clerical: We supply administrative support staff, including receptionists, office managers, administrative assistants, and clerical personnel.
We are proud of the company we keep and are honored to have a strong array of clients who put their faith in us to help their business flourish. Our wide range of clients includes several of the top fortune 100 companies. Further, to support a balance between work and home life, Hired by Matrix has elected to be a 100% distributed work environment. This approach allows us to support our clients in the way they work, when they work.
Why Hired by Matrix?
Extensive Industry experience: With years of experience, we possess in-depth knowledge and understanding of our specific staffing requirements and challenges across different industries.
Long Term Relationships: Exceptional relationships with multiple clients that expand over 2 decades.
Exceptional Talent Pool: Our vast network and comprehensive candidate database allows us to connect business with highly skilled professionals who meet their specific criteria and culture fit.
Quality screening: We conduct rigorous screening and assessment processes to ensure our candidates possess the necessary qualifications, skills, and experience required by our clients.
Customized Solutions: We tailor our staffing solutions to meet the unique needs and preferences of each client, providing flexible and scalable options that align with their organizational goals.
Dedicated Customer Support: Our Dedicated team is committed to delivering excellent customer service, providing ongoing support through our Consultant Appreciation Program which provides guidance throughout the onboarding process and beyond.
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