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Program Manager / Quality Manager
Our growing company is searching for a motivated leader to fill a dual Program Manager / Quality Manager role.
As a Program Manager, you will act as a consistent point of contact for Design Science clients. You will monitor project execution, including establishing internal and external timelines, tracking milestones, and managing budgets/invoicing.
As Quality Manager, you will oversee and administer the company’s quality management system, including leading the QMS team, developing and enforcing compliance with policies and procedures, conducting internal and supplier audits, investigating and resolving non-conformances, and ensuring timely resolution of CAPAs. Additionally, the Quality Manager performs and oversees quality checks on outgoing company deliverables to ensure clients receive accurate and consistent outputs.
- Bachelor’s degree in engineering, business, or related field (i.e., product design and development). Minimum 3 years of client or internal stakeholder management experience at a medical device manufacturer, pharmaceutical manufacturer or relevant consultancy.
- Minimum 2 years of project management experience.
- Strong understanding of quality systems and product/process lifecycle management.
- Deep knowledge of international standards, including ISO 9000, 9001, and 13485.
- Experience with designing medical devices and FDA regulations for medical device quality systems (i.e., Title 21 CFR Part 820).
- Strong knowledge of project management and sales principles, methods, practices, and techniques.
- Experience with risk management as applied to product development.
- Evidence of collaboration with colleagues in other disciplines such as human factors, software development, mechanical and electrical engineering, industrial design, visual design, and marketing.
- Proven track-record of ability to successfully lead a team towards a common goal.
- Ability to think creatively and solve problems in time sensitive situations.
- Strong written and verbal communication.
- Incredible attention to detail.
- Ability to work full time at a Design Science office and to travel up to 20-30% of the time, domestically and internationally.
- Willingness to undergo background checks and drug/health screenings as required.
- Project and client management
- Proposal writing/execution
- Conduct internal and client-facing project kick-off meetings
- Deliverable planning
- Client sales presentations
- Project budget review/invoicing
- Management of scope of work change requests/billing issue mediation
- Participation in planning meetings
- Participant recruitment management
- Equipment management (i.e., inventory, purchasing)
- Coordinate with executive team to set quality policy
- Communicate company’s quality policy and objectives annually
- Lead QMS team in successful execution of quality policy and objectives
- Act as main client contact for quality issues/customer complaints
- Schedule and conduct internal and supplier audits
- Ensure non-conformances are resolved per policy
- Develop internal standard operating procedures and related training content as needed
- Collect, analyze, and communicate quality metrics
- Monitor updates to applicable standards (e.g., ISO 9001) and ensure integration into policies, procedures, and work instructions
- Manage quality tools (e.g., PolicyTech)
How to apply:
Interested candidates should submit resume and cover letter to careers[at]dscience.com
Don’t see the right position for you?
That’s okay, we know talent when we see it. If you have expertise in one or more of the following areas, we would love to hear from you. If you want to know what life is like with Design Science, be sure to check out our Instagram.
- Human Factors
- Observational Research
- Information Design
- User Interface Design
- Usability Testing
- Systems Engineering
- Medical Device Design