About Beyond Hosting
Sourced by ZipRecruiter
Company size
1 - 10 Employees
Headquarters location
West Chester, OH, US
Year founded
2010
$99.30K - $198.70K/yr
Full-time
Medical
Posted 28 days ago
Job description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Design Controls Manager – REMOTE. As a key player in ensuring compliance and efficiency in design control processes, you will collaborate closely with various departments including Regulatory, Quality, and R&D.
Your expertise will be critical in driving improvements across product development processes, ensuring adherence to global regulatory standards while supporting timely product releases. This role not only influences product outcomes but also involves shaping the culture of compliance and excellence within the organization. Accountabilities Partner in optimizing and streamlining design control requirements for medical devices.
Lead process development and improvement projects with cross-functional teams globally. Conduct and develop training on design controls and related process changes. Ensure conformity of processes and records to global regulatory standards.
Audit design records to ensure compliance and address non-conformances. Perform gap analyses against international regulatory standards and propose updates. Maintain expertise in global design controls and related standards.
Mentor R&D and Quality Assurance teams to align with policies and procedures. Participate in audits as a design controls expert and company representative. Collaborate with R&D to ensure compliance in software tool implementations.
Requirements BS in Management, Engineering, or Science preferred, or equivalent experience. 5+ years of Quality or R&D experience in a medical device company. In-depth knowledge of Quality System Regulation (QSR), ISO 13485, and MDSAP.
Expertise in QMS subsystems including CAPA, audits, risk management, and design control. Experience leading design processes in a medical device context. Demonstrated leadership and ability to influence and communicate globally.
Strong written, verbal, and interpersonal communication skills. Ability to work independently and collaboratively. Willingness to travel 25% including international trips.
Competitive salary range from $99,300.00 to $198,700.00. Flexible remote work environment. Opportunities for professional development and training.
Collaborative and innovative team culture. Comprehensive health benefits and wellness programs. Potential for periodic international travel.
Support for continuing education and certifications. Access to cutting-edge technologies and methodologies. Why Apply Through Jobgether?
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
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beyondhosting.net
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Frequently asked questions
Q: What skills or qualities help someone succeed as a Internal Controls Manager?
A: To succeed as an Internal Controls Manager, key technical skills include proficiency in accounting standards, financial regulations, and risk management frameworks, as well as expertise in auditing and compliance procedures. Soft skills such as strong analytical and problem-solving abilities, effective communication and interpersonal skills, and the ability to work collaboratively with cross-functional teams are also essential. These strengths enable Internal Controls Managers to identify and mitigate risks, ensure regulatory compliance, and drive process improvements, ultimately supporting career growth and effectiveness in the role.
Q: What is the career path for a Internal Controls Manager?
A: A typical career progression for an Internal Controls Manager involves starting as an Internal Auditor or Financial Analyst, progressing to a Senior Auditor or Compliance Officer, and eventually becoming a Manager of Internal Controls, overseeing the development and implementation of internal controls across the organization. Key opportunities for skill development and professional growth in this role include gaining expertise in risk management, auditing, and compliance, as well as developing strong analytical, communication, and leadership skills. Long-term career prospects for an Internal Controls Manager may include transitioning into senior leadership roles, such as Chief Audit Executive or Chief Risk Officer, or pursuing specialized certifications like the Certified Internal Auditor (CIA) or Certified Information Systems Auditor (CISA).
