Director of Quality, Software Quality and Integration

Who we want:

Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures

What you will do:

Manage part of a business unit with full responsibility of new product development (design) and post market (customer) product quality. Leads a team of engineers and other managers to deliver on key business quality goals by launching high quality products as well as delivering on effective product quality improvements in post market. Work closely with customers and salesforce including travel when needed. May lead teams across multiple geographies. Manage financial cost center(s) and responsible for all hiring, development and performance management activities.

Essential duties & responsibilities: (detailed description)

• Responsible for new product development (design) quality as well as post market (customer) quality

• Provide a strategic direction and tactical focus to the Quality Engineering organization and influence the direction of business unit product Quality and Design Assurance activities.

• Responsible for establishing metrics/KPIs for quality

• Capable of leading a team of engineers to deliver relentless product quality improvements in post market and support customers/field teams with a sense of urgency

• Conducts periodic Quality review with senior leadership within the division and responsible for providing data /state of affairs of product quality in the field

• Actively involved in new product design and development teams to launch new products with high quality that meet user needs (including safety, reliability etc.)

• Responsible for ensuring the quality and compliance of all products to Regulatory Standards within FDA and international guidelines.

• Designs, develops, and implements comprehensive quality engineering programs.

• Responsible for ensuring, tracking and reporting quality and reliability for released products.

• Responsible for reviewing engineering changes to products via internal change control system for product changes.

• Maintains and manages cost centers for team

• Leverages relationships with cross functional leaders within business unit to set and achieve key product quality goals

• Responsible for supporting complaint handling, MDR-MDV reporting and product field action decisions.

• Participates and provides support during FDA and regulatory audits

• Ensure that manufacturing, product development, and related functions are conducted in compliance with international standards and government regulations in support of company mission.

• Chair meetings required to drive closure of quality issues.

• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.

• Recruit, select, and on-board top talent as well as improve team capability, impact (ROI) year over year

• Develop talent within team to increase performance. Actively address performance issues on team.

• Maintain a high level of team engagement.

• Travel up to 30%

Education & special trainings:

• Bachelor's degree required, preferably in Computer Science, Engineering, Information Technology, or equivalent field experience

• Six Sigma experience, CQE/CQM/PE certification preferred.

Qualifications & experience:

• This is a management position that contributes and achieves results through others. The role is responsible for managing subordinates in professional jobs or managing through subordinate managers / supervisors or is a leader of process that achieves results through others, whom are not direct reports. Job requires a broad and comprehensive understanding in multiple disciplines relevant to the business. The job is expected to establish strategic plans and/or operational programs that require a sound understanding of the underlying theories underpinning the subject area. The job has full management responsibility including the management of numerous teams of managers/professionals, planning for the teams' future needs and operations. There will be financial accountability for independent budgets.

• Minimum of 12 years experience in a design and product development environment preferably in Medical Device industry

• Minimum 4+ years of management experience

• Must be able to communicate with and inspire large groups of people.

• Must be able to review technical documentation

• Must be able to generate and explain detailed proposals, guidelines, and procedures for the Quality function to departmental and/or non-departmental personnel.

• Must be able to analyze and resolve non-routine product issues using independent judgment.

• Must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.

• Must be able to observe and correct inconsistencies across business/team

• Excellent analytical and root-cause skills.

• Excellent interpersonal skills.

• Demonstrated effective managerial skills.

• Excellent organizational skills.

• Comfortable putting together presentations frequently and presenting to senior leadership

• Comfortable communicating with customers and field teams

• Highly accountable for results

• $160,000 - $260,000 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Actual minimum and maximum may vary based on location.  Individual pay is based on skills, experience, and other relevant factors.
• This salary range is based on the current available market data and represents the expected salary range for this role. A broad range of experience is represented within roles. Should you have compensation expectations that exceed these bands, we'd love to hear from you and would welcome you to reach out to discuss further.