Pirouette Medical

We make injections as easy as pushing a button!

Vice President, Quality Assurance (QA) and Regulatory Affairs (RA)

$200k - $250k / 0.00% - 0.50%
Location
Portsmouth, NH / Remote
Job Type
Full-time
Experience
11+ years
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Matthew Kane
Matthew Kane
Founder

About the role

Vice President, Quality Assurance (QA) and Regulatory Affairs (RA) Full-Time (On-site, remote)

Company Description: At Pirouette, we have developed a low-profile, disk-shaped, rugged injection device (auto-injector) with a patient-centric focus on affordability, portability, and usability. The patented device, based on extensive patient input, is designed to make administering an injection as easy as pushing a button. This allows individuals with limited or no training to easily and intuitively perform an injection on themselves or others.

Position Description: This is an opportunity to join as the Vice President of Quality Assurance and Regulatory Affairs (VP, QA/RA) of a venture backed Medical Device organization, reporting directly to the COO. The successful candidate will contribute to creating and implementing the overall business strategy and direction and will serve as the leader for all Quality Assurance and Regulatory Affairs at Pirouette. This individual will act as an advisor, consultant, and subject matter expert within Pirouette, providing guidance and expertise in areas related to quality, compliance, and regulations. They will be responsible for setting the strategic direction for the company’s quality and regulatory policies and procedures. This position will introduce and lead transformational efforts for improving product quality and driving the culture of quality. The successful candidate will be overseeing the compliance of the Quality Management System (QMS) to industry Standards and FDA requirements specific to the markets where the product(s) will be commercialized. The successful candidate will also plan and implement the overall supply chain strategy through participation in supplier qualifications, audits, ongoing monitoring, and ongoing supplier continuous improvement action plans. The initial device under development is a drug-device combination product, and this role will be instrumental in this product and subsequent product lines.

Location: Portsmouth, NH preferred, remote acceptable. Travel is expected from time to time for in-person meetings and travel to suppliers/CMOs to monitor and validate compliance as well as to coordinate audits by Pirouette, other suppliers/CMOs, and regulatory bodies (e.g., FDA).

Key Responsibilities: Responsible for development, implementation, maintenance and overall success of the company’s quality assurance and regulatory affairs programs and strategy; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing vendor relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality. Responsible for driving effective and efficient Quality Management System (QMS), while ensuring QMS is established well with appropriate business processes in the company. Works to create and support process enhancement initiatives that deliver an environment of continuous improvement and high-quality output. Apply engineering, leadership, and Quality Assurance skills to effectively develop and manage Pirouette’s QMS to industry Standards and FDA requirements in combination with utilizing the best industry practices for assuring the product safety and reliability. Manage the day-to-day quality activities and ensure the QMS (i.e., complaint handling, incoming QA inspection, document control processing, monitoring/dashboards, etc.) is adequate. Coordinate the performance of the future Site Management Reviews and the Post-Market Surveillance Reviews. Oversee the Quality Training Program ensuring that Pirouette and supplier/CMO employees are trained on and adhere to the current SOP’s, work instructions, and safety requirements. Perform the Quality assessments and market strategies for new and existing products. Lead and direct the efforts of the internal and external Quality team members to ensure that manufacturing related processes and activities comply with the FDA regulations and Pirouette’s Quality Management System (QMS). Collaborates with other functional teams to identify, investigate and resolve product quality issues in a compliant and effective manner as well as establishing the service level agreements (SLA) for response and corrective actions. Supports and participates in FDA, Notified Body and other audits. Ensure complaint investigations are conducted in a timely manner and in accordance with medical device regulations and Pirouette’s Quality Management system Plan and implement the overall supply chain strategy and integrate those third parties with Pirouette’s Quality Management System (QMS). Participate in supplier qualification, audit, ongoing monitoring, and supplier continuous improvement action plans. Develop and implement supply chain key performance indicators (KPIs). Suggest solutions for quality and manufacturing process improvements. Work with internal and external personnel to determine best suppliers and distributors. Build and maintain good relationships with suppliers. Develop and deploy Quality System related processes, tools, training, and metrics to enable Pirouette to meet business needs and comply with FDA regulations. Lead CAPA, post market surveillance and other quality improvement efforts after launch. Establish a dashboard for monitoring and communicating key quality trending information and data for use in periodic reviews. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Use of 8D methods is expected when working root cause analysis and corrective action plans. Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). Oversees the development of employees, talent, process, and technology necessary to reach annual and long-term objectives as organizational leader for Quality & Regulatory Assurance functions. Responsible for managing and maintaining assigned budgets, and communicating changes in the required budget rapidly. Other duties as assigned, according to the changing needs of the business.

Required Skills and Experience: 11+ years of managerial/leadership experience in Quality Assurance, Quality Engineering, and Regulatory Affairs in the life sciences area. Bachelor's Degree in a science or engineering discipline, Master's Degree preferred. Experience with drug-device combination products, 510(k), NDA ( e.g., 505(b)(2) ), and/or PMA submission process (or global equivalent) for Class I and/or Class II and/or Class III medical devices. Experience with Lean Six Sigma, KPIs, dashboards, and lean manufacturing programs. Prior experience in a senior leadership role setting strategic direction for the company's quality & regulatory policies and procedures is required. Consistent track record of success in audits and compliance, and interaction with notified bodies. Strong track record of change management and success working cross-functionally. Strong manager and leader with the ability to attract talent and build a team. Can establish goals/objectives that they can execute independently. Able to travel domestically and internationally Experience working with QMS compliant to 21 CFR 820, ISO:13485, and 21 CFR 211. Fully competent with all aspects of development and maintenance of the QMS, owning CAPA processes and carrying them out, deviations, SOP writing, audit readiness. Experience with various QMS software, especially Greenlight Guru, Master Control, or similar. Experience interfacing with Notified Bodies and State Regulators in an audit capacity. A willingness and ability to wear multiple hats, operate independently, and as part of a team in a small organization setting where a self-starter personality is key.

Compensation: Salary Range: $200K - $250K, pending experience. Benefits: Medical, Dental, Vision, Disability, Life. PTO: Discretionary: Similar to unlimited vacation policies, employees using discretionary PTO don’t have a designated number of paid time off hours. Instead, employees collaborate with their direct supervisors to determine what vacation days they can use and when. Stock Options: Yes, pending experience.

Other: Pirouette Medical is an equal opportunity employer, meaning we consider applicants for employment and make employment decisions without unlawful regard to sex, race, color, religion, citizenship, national origin, ancestry, sexual orientation, age, marital or domestic partner/civil union status, military service, veteran status, physical or mental disability, or any other protected characteristic under applicable law.

Why you should join Pirouette Medical

At Pirouette, we have developed a low-profile, disk-shaped, rugged injection device with a patient-centric focus on affordability, portability, and usability. The patented device, based on extensive patient input, is designed to make administering an injection as easy as pushing a button. This allows individuals with limited or no training to easily and intuitively perform an injection on themselves or others.

Pirouette Medical
Founded:2017
Team Size:5
Location:Boston
Founders
Conor Cullinane
Conor Cullinane
Founder
Matthew Kane
Matthew Kane
Founder
Elijah Kapas
Elijah Kapas
Founder