Quality Assurance Program Manager
2 weeks ago
Position: Quality Assurance Program Manager
Client: Medical Device Manufacturing Firm
Duration: Contract Position
Location: Remote with Onsite Requirements
Key Qualifications:
- Proven Program Management Experience in Design Controls, Risk Management, and Quality Systems for FDA-approved medical products.
- Expertise in Budget and Resource Planning for project deliverables.
- Strong Leadership Skills with the ability to manage teams effectively as an individual contributor.
The primary function of this role is to oversee a program focused on the transition of medical devices between business units. This includes conducting gap analyses for products and quality management systems to identify necessary record remediation. The candidate will be responsible for developing a Quality Plan that outlines project activities and resource allocation. The ideal candidate should possess:
- Oversight capabilities for the creation and upkeep of quality programs, systems, processes, and procedures that ensure adherence to policies and maintain service quality in line with established standards.
- Expertise in interpreting policies and regulatory requirements to ensure compliance.
- Direct engagement with operational teams to provide ongoing process analysis and enforce compliance with regulations.
- Preparation of necessary documentation (e.g., Quality Plans) for relevant stakeholders.
- Regular updates and modifications to quality assurance programs and policies.
Educational Background:
Bachelor's Degree in Engineering or Science
Experience Required:
8+ years in relevant fields
Responsibilities may include, but are not limited to:
- Oversight of quality program development and maintenance.
- Guidance in regulatory interpretation and compliance assurance.
- Collaboration with operational entities for continuous process oversight.
- Preparation for audits and inspections, addressing findings, and liaising with auditors.
- Documentation preparation for stakeholders, including Corrective and Preventative Actions.
- Coordination of legal inquiries related to investigations or litigation.
- Maintenance and regular updates of quality assurance policies.
- Facilitation of global standards and best practice sharing to support the company's mission.
- Accountability for program performance and customer satisfaction.
Impact on Organization:
- Input on program objectives, timelines, and budgets.
- Recommendations for new policies affecting program management.
- Potential budget accountability for multiple programs.
- Program decisions made in consultation with senior management.
Innovation and Complexity:
- Addressing complex problems requiring thorough analysis and investigation.
- Challenges typically affecting multiple departments or specialties.
- Modification of program management processes for improvement.
Communication and Influence:
- Leading meetings with internal and external stakeholders and presenting to senior management.
- Resolving issues through effective communication and persuasion.
- Involvement in daily tasks essential for successful program execution.
- Not directly responsible for personnel decisions.
Required Knowledge and Experience:
- Practical knowledge in managing processes and projects within a specific area.
- Advanced skills in a technical or professional discipline with an understanding of organizational impact.
- Baccalaureate degree or equivalent experience with a minimum of 5 years in relevant roles, or an advanced degree with at least 3 years of experience.
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Company OverviewThree Point Solution is a premier contract, contract-to-hire, and professional placement firm dedicated to aligning clients with the right resources at the right time. We pride ourselves on delivering exceptional service that benefits our clients, candidates, and employees. Unlike larger recruiting firms, we focus on personalized attention, bridging the communication gap between recruiters, employers, and candidates. Our mission is to foster and maintain genuine partnerships with all stakeholders.
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