Quality Systems Program Manager

Job Description

Job Description

Job Title : Quality Systems Program Manager

Client : Medical Device Manufacturing Company

Duration : 6 months

Location : Minneapolis, Minnesota 55432

Shift : 1st Shift (Onsite 3 days per week : Tuesday / Wednesday mandatory, plus choose Monday, Thursday, or Friday as the 3rd day in office)

HM's Top Needs :

• Experience with Program Management for Design Controls, Risk Management, and Quality Systems for FDA PMA-approved or 510(k)-cleared products.
• Developing budget / resource planning for deliverables.
• Excellent team management skills, leading a team as an individual contributor.

This role's primary responsibility will be to lead a program that involves transferring medical devices from one Client business to another.

It will include gap assessments for products and the quality management system to determine if any remediation of records will be required.

It involves creating a Quality Plan to document project activities and to identify resources to perform those activities.

The ideal candidate should have the following :

• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and / or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Prepares reports and / or necessary documentation (e.g., Quality Plans) and provides to applicable stakeholders, both internal and external.
• Ensures the quality assurance programs and policies are maintained and modified regularly.

Education Required :

Bachelor's Degree in Engineering or Science

Years' Experience Required :

8+ years

Responsibilities may include the following and other duties may be assigned :

• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and / or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and / or necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Coordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.
• Is accountable for overall program process, performance, and customer satisfaction.

Organizational Impact :

• Provides input to establishing program objectives, timelines, milestones, and budgets.
• Recommends new policies and procedures that affect program management.
• May have budget accountability for one or more programs.
• Program decisions are generally made only after consultation with higher-level management.

Innovation and Complexity :

• Problems faced are difficult and require detailed information gathering, analysis, and investigation to understand the problem.
• Problems typically impact multiple workstreams, departments, or specialties.
• Modifies program management processes to improve the program.

Communication and Influence :

• Communicates and leads meetings with internal and external customers and vendors, and conducts briefings to higher-level management teams.
• Solves issues through information exchange, influence, and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
• Direct involvement in daily tasks necessary for successful program execution.
• Not directly responsible for hire or fire decisions and people management.

Required Knowledge and Experience :

• Requires practical knowledge in leading and managing the execution of processes, projects, and tactics within one job area.
• Typically has advanced knowledge and skills within a specific technical or professional discipline with an understanding of the impact of work on other areas of the organization.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.

F.R. 214.2(h)(4)(iii)(A)) and a minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience.

Company Description

As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time.

We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate.

Our goal is to cultivate and maintain true partnerships with our clients and candidates.

Company Description

As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time.

We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate.

Our goal is to cultivate and maintain true partnerships with our clients and candidates.