Quality and Program Manager-Philadelphia or Chicagoland

Company Description

Design Science is a human factors research firm, founded in 1991. Our mission is to amplify the needs of patients, their caregivers, and healthcare professionals in order to cultivate the advancement of healthcare technology. We do this in partnership with some of the world’s leading medical device and pharmaceutical companies, harnessing the skills of members of our organization in human factors research, design, and video to collect important insights about how users interact with medical products. Research results in outcomes like easier and faster therapies, and ultimately, a better quality of life for patients.

Design Science is headquartered in the heart of Philadelphia, PA, with newly opened offices in Evanston, IL and Munich, Germany. We have over 30 employees working across our three locations. Our team is made up of diverse, talented, caring individuals who value socially impactful work in a collaborative culture. We offer the opportunity to grow as a professional, experiencing a wide variety of projects and clients in a growing organization.

Job Description

Overview:

Our growing company is searching for an agile leader to fill a dual Quality Manager / Program Manager role. This position can reside in Chicagoland or Philadelphia.

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 nonconformances, 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.

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.

Quality Manager Responsibilities:

• 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 nonconformances 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)

PM Responsibilities:

• 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 mgmt. (i.e., inventory, purchasing)

Qualifications

• 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.
• Strong verbal/written communication skills.
• Ability to manage multiple projects at once with keen attention to detail.

• 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.
• Ability to work full time at a Design Science office and to travel up to 20-30% of the time, domestically and internationally.
• The finalist will be required to undergo background checks and d