If you are interested in a career with OrthoGrid, please view our current job openings.
VP of Quality & Regulatory
The Vice President Quality and Regulatory is responsible for managing and directing the quality management system and the regulatory activities within the company to ensure compliance with all applicable standards, regulations, and customer requirements. This position will communicate and lead cross departments with Product Development, Regulatory, Marketing and Sales to ensure goals and strategies are met.
- Ensure all products are safe for consumers and compliant with all government regulations where product is distributed. Standards and regulations include but are not limited to ISO 13485:2016, 21 CFR 820, Australia TGA, Europe MDD and MDR, and Japan JPAL.
- Establish, maintain, and oversee robust quality systems including QMS documentation, internal audits & corrective/preventive actions, document/data control, material review (nonconforming material) and establishment and maintenance of quality records.
- Ensure all manufacturing facilities including supplier locations have appropriate Quality Systems and meet all government regulations.
- Provide Quality and Regulatory direction & support during pre-production, production, and post-market.
- Drive internal corrective/preventive actions & ensure the effectiveness of the quality management system.
- Install and maintain ISO certification as required; perform duties as Management Representative.
- Prepare and coordinate the preparation of pre-submissions, De Novo requests, 510(k) submissions, and Technical Files for CE marking.
- Manage risk mitigation activities, and work with business teams to minimize exposures and risks as appropriate.
- Support efforts to build Quality into all products, including prelaunch evaluation of new products.
- Support efforts to reduce manufacturing costs and improve efficiencies.
- Prioritize and direct the work of the Quality and Regulatory staff and communicate timetables regularly to insure commitments are met.
- Provide coaching, mentoring, advice, guidance, counseling, and direction to staff.
- Recruit and train personnel to maintain a position of technical excellence. Set high standards for performance, hire qualified professionals, and provide necessary resources and training for staff to perform at optimum levels.
- Build appropriate relationships with Operations, R&D teams, Marketing, and Sales, and provide on-going support as needed.
- Work with suppliers, Quality, Operations, and R&D to ensure team alignment and clear objectives as appropriate.
- Participate as an effective member of cross-functional teams.
- Work with cross-functional teams to develop technical strategies that support current and long-term business objectives.
- Ensure that all projects agreed upon are executed in a timely manner and deliver the expected results.
- Responsible for the preparation and management of the Quality and Regulatory departmental budget.
- Plan and implement global Regulatory Affairs strategies, policies, objectives, and submissions in accordance with Company strategic plans.
- Provide on-going support to the product development teams for regulatory and quality issues and questions.
- Provide measurement tools and guidance for measuring manufacturing performance, such as First Pass Yield, In-Process Test/Inspection results, etc.
- Oversee calibration, inspection and testing programs.
- Prepare & provide periodic reports of Quality Metrics to Management, as required, including scrap, first pass yield, audit results, corrective actions, customer feedback, customer complaint, supplier metrics, etc.
- Establish & maintain effective customer relationships.
- Investigate and respond to customer complaints. Appropriately report customer complaints to regulators.
- Oversee returned goods analyses, gather, and interpret data, and provide effective feedback to customers.
- Incorporates company vision and values into day-to-day activities and behaviors; guides and motivates others to remain committed to the Quality Policy.
- Perform other duties as assigned.
- Bachelor’s degree in Engineering, Technology, or other life science degree.
- 7+ years in quality system development, regulatory activities, implementation, and compliance experience in the medical device industry.
- 3-5+ years of medical device software experience, preferred.
- Working knowledge and experience in the following areas: Quality System Management, US and OUS Regulatory, Document Control, Design Control, Design V&V and Process Validation, Design Transfer, Risk Management, Complaint handling, Vigilance Reporting, CAPA management, Supplier Control, etc.
- Demonstrated ability to successfully work with individuals and cross-functional team environment.
- Strong ability to influence and work with personnel at all levels.
- Good organization, interpersonal, negotiation, time/project management, motivational, and judgment skills.
- Demonstrated ability to effectively lead facility inspections conducted by Regulatory Agencies.
- PC proficient (e.g., Windows, Word, Excel, PowerPoint).
Quality Assurance Service Engineer
The Quality Assurance Service Engineer for this growing software medical device company is responsible to develop and improve our customer support processes within the quality system. A successful candidate will need to understand software systems, how they relate to the quality system, and work with the customers and departmental teams to receive and document complaints.
- Provides technical assistance to customers or company employees to identify and resolve customer issues over the phone, email, or customer relationship software.
- Assist in the diagnosis of software and hardware performance issues and work with product development on solutions.
- Document customer complaints and coordinate complaint process, including creating complaint files, setting up complaint team meetings, gathering final complaint documents and storing records.
- Work closely with the Development team to confirm and classify software defects.
- Provide customer installation support and software maintenance for customers.
- Assist with management of the quality policy, quality system procedures, and practices that meet customer, FDA, and regulatory requirements.
- Assist in the development of quality related training programs.
- Create installation qualification documents, site and service documentation, and other related paperwork.
- Bachelor’s degree in technology, or other life science degree.
- 3+ years in quality system experience in the medical device industry.
- Experience with customer relationship software.
- Excellent customer interaction skills, including the ability to handle and diffuse challenging situations while maintaining a calm and positive attitude.
- Excellent oral and written communications skills.
- Experience with Linux operating systems.
- Experience using common networking tools such as SSH, SFTP, and VPN.
- PC proficient (e.g., Windows, Word, Excel, PowerPoint).
Regional Sales Executive
A great growth opportunity for someone with five years of sales experience, the Regional Sales Executive will have an executive presence, will know how to cold call and can positively interface with decision makers, including Surgeons, OR Directors, Radiologist Technologists, Purchasing Managers, and CFOs.
- Develop and execute a sales performance strategy to include new accounts, current accounts, and lost accounts.
- Identify all perspective opportunities both individually and together with distributor partners in defined territory.
- Report number of prospects, targets, facilities, and surgery centers in a formal structural context and report to management.
- Develop an effective call cycle to create frequency and pressure on identified targets and opportunities in defined sales territory.
- Be the product expert, confident in all aspects of OrthoGrid product portfolio.
- Handle initial account negotiations for all assigned OrthoGrid facilities (DPs potentially).
- Establish productive, professional relationships with key opinion leaders, including doctors, hospitals, surgery centers, implant distributors, and sub-distributors.
- Coordinate the involvement of company personnel, including support, service and management of resources to meet account (surgery center/distributors) performance objectives, and customer expectations.
- Partners and works efficiently with both direct and indirect sales representatives.
- Educate, manage, and support distributor partners in defined territory.
- Achieve assigned sales targets for profitable sales volume and strategic objectives.
- Achieve yearly revenue goals through procuring the right mix of doctor and facility growth.
- Track targets, leads, and pending purchase orders in CRM.
- Attend academic meeting, tradeshows, and sales conferences to promote and represent OrthoGrid Solutions.
- Bachelor degree (B.A. or B.S.) from a four-year college or university or equivalent combination of education and experience.
- 3-5+ years of orthopedic sales/medical software sales/sales management experience, including significant prospecting and relationship development/management with documented results.
- Demonstrated success in a previous sales role as an independent contributor.
- Demonstrated success in building, coaching, and leading an independent sales distribution channel is preferred.
- Possess solid clinical and technical expertise in orthopedic arthroplasty and trauma procedures.
- Strong relationships with orthopedic surgeons and/or surgery personnel.
- Experience in one or more areas of total joint arthroplasty, hip preservation, and or/and orthopedic trauma is preferred.
- Must have a valid driver’s license.
- Must be able to travel within a defined territory. Up to 50% overnight travel may be required.
Product Manager - Software
The Product Manager is a passionate, self-starter who thinks strategically, executes with detail, and is a customer-oriented and focused individual. Reporting to the VP of Marketing, the Product Manager plays a key role in shaping OrthoGrid’s product roadmap through competitive and insightful product positioning, go-to-market strategies, and pricing analysis. This individual will be responsible for generating global customer insights, establishing customer requirements, and coordinating the creation of the strategic roadmap for our technology platform and the flawless execution of key product launches that push the OGS brand and technologies forward in the marketplace.
- Work with a cross-functional teams to promote, launch, and educate about products globally, including pre-FDA clearance and initial market validation.
- Own user and product insights: Go deep on understanding how users engage across our B2B technology platforms and various market segments.
- Generate actionable customer insights by executing primary and secondary research, visiting surgeons / customers, participating in advisory board discussions, attending society meetings, and engaging regional partners.
- Represent voice of the customer in team discussions to guide trade-offs and product feature / design decisions.
- Build data-driven, actionable insights that inform product, sales, and marketing strategy.
- Innovate on our go-to-market approaches.
- Engage with internal and external partners to test new channels to increase engagement and /or drive new customer acquisition.
- Work collaboratively to define and secure new clinical studies and narratives to drive growth and engagement in key market segments.
- Develop and update financials and ensure team alignment with key assumptions.
- Identify and prioritize new areas of marketing opportunity to amplify audience engagement that lead to new customer acquisition using Sales insights and data.
- Coordinate with various departments (R&D, Sales, Creative, Finance, remote teams, etc.) on product marketing, trade show, and launch strategy per product line.
- Develop surveys to validate campaign assumptions and strategic proposals.
- Collect necessary market intelligence and competitive analysis.
- Provide regular updates, presentations, marketing plan updates, and SWOT analyses as required.
- Develop strategies that lead to increase in trials and demos generated from product launches and new customer relationships across all product lines.
- Evaluate the strategic and financial attractiveness of growth opportunities, including disruptive technologies, minimally invasive/robotic surgery solutions, and advanced therapies/products to improve patient outcomes.
- Conduct in-depth assessment of new markets and emerging technologies/therapies to recommend the best entry strategy.
- Lead market assessment and business case development.
- Collaborate as needed with functional partners to support strategic planning and portfolio optimization projects.
- Own market and financial analytics, including market models, financial performance, and project valuation.
- Bachelor’s Degree in Marketing or related field, MBA preferred.
- Minimum 2-3 years of marketing experience, with 1+ year of experience in software product management.
- Must have MedTech or software industry experience.
- Proven track record of developing and executing high impact, multi-channel, go-to-market efforts for B2B solutions.
- Proven track record of driving results with marketing strategy development and execution.
- Commercialization/product launch experience.
- Excellent analytical, problem-solving, and critical thinking skills.
- Hands-on experience with complex market and financial analysis.
- Adept at leading, influencing, and communicating with diverse cross-functional teams.
- Excellent communication, written, oral, and presentation skills.
- Strength in Excel and PowerPoint.
- Self-starter, results driven, and competent managing multiple priorities simultaneously.
- Experience using market research to inform product development strategies.
- Track record of driving rapid growth of innovative technologies.
If you are interested in applying for a position with OrthoGrid, please click the link below and email your resume to our Human Resources department:
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