Job Description Summary
Reporting to the Associate Director, Quality Assurance, the Sr. Manager, Quality Assurance provides expertise and input from a software life cycle perspective on the Design and Development of Infusion products.With an emphasis on software lifecycle, the manager will focus onimproving product safety, product quality, and compliance with applicable regulations (e.g., ISO 62304).Effective communication with all Core Team members, and multiple levels of the Quality organization is required for success.Problem solving and active management of ambiguous situations is needed.Success is measured in terms of the frequency and scale of product quality and organizational issues as well as business process effectiveness. Through internal and external stakeholder engagement and personnel development, the Manager, Quality Assurance ensures projects produce high quality products, compliant project deliverables and improved QMS processes.
Primary Responsibilities and Duties
- Manage Quality Engineers on multiple projects, with emphasis on software development and test activities and documentation.
- Mentor and develop personnel, including dedicated succession planning and contingency management.
- Provide guidance and leadership in QMS development processes, with emphasis on software life cycle.
- Effectively partner with R&D to define deliverables and troubleshoot technical issues. Engage with (or may lead) quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision.
- Ensure effective design transfer between development and manufacturing
The Sr. Manager, Quality Assurance Engineering position is responsible for: improving design control processes, managing Quality resources, providing guidance and leadership to cross-functional project teams to meet the needs of the WW business and conform to all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality and Regulatory Compliance Policies.
Aids in the development, implementation, and improvement of an effective quality system that meets appropriate WW Business, Division, Corporate, Government, and International Standards for efficacy, safety, quality, and customer satisfaction. Primary point of contact for such improvements in areas related to software life cycle and applicable standards.
Serves as Quality resource for complex new product development projects. Ensures successful development, verification, validation, and transfer of design.
- Establishes and leads business and functional strategies / objectives.
- Considered an expert in their functional knowledge and expertise to the business. Provides subject matter expert to internal employees and software teams with regard to software development and test in a medical device environment.
- With primary focus on software life cycle, must keep current with US and International regulations affecting product development, manufacturing and WW commercialization. Interprets and communicates changes to the business and project teams.
- Carries out Management responsibilities such as the hiring, job assignments, performance planning and talent development, salary actions, performance reviews, and termination recommendations.
- Perform other related duties and assignments as required.
- Excellent analytical, technical, and problem solving skills (TQM or Six Sigma experience preferred).
- Excellent and experienced meeting and presentation skills (presents at Trade Shows / Conferences).
- Ability to perform multiple tasks / large projects and to prioritize work load for function.
- Effectively / actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties
- Ability to work in and to direct teams to obtain results.
- Knowledge and experience in financial management, planning, and organizational skills.
- Excellent analytical, technical, and problem-solving skills.
Scope of Responsibility:
- Establishes and drives implementation of strategy and direction.
- Ensures effective implementation for the assigned quality function in alignment with strategic plans established with top management and executive leadership. Contributes to business strategies and plans.
- Advances the global leadership bench strength of the company.
Sphere of Influence:
- Interacts both internally and externally with senior-level management, requiring negotiation of extremely critical matters. Influences decision making (e.g. via the PDT). Understands and works to improve effectiveness of the BD matrix.
- Considered Site / functional level Subject Matter Expert.
- Directs and controls the activities of multiple Quality Engineering core team members.
- Bachelor’s Degree in Engineering
- A minimum of 9 years in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.
- A minimum of 3 years directly managing Quality professionals.
- Must have extensive, expert level knowledge of the software development and test life cycle. Must have full knowledge and experience with ISO 62304, ISO 13485 and 21CFR820.
- Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements.
- Software life cycle, statistics, technical writing.