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Manager, Complaints and Post-Market
About The Team
The Quality team is an integral part of ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements. We are a team of detail-oriented professionals who take pride in meticulously assessing processes, products, and services to identify and rectify issues, ensuring the utmost quality and customer satisfaction. If you share our passion for maintaining the highest standards of quality and are dedicated to making a positive impact, we invite you to consider joining our Quality Assurance Team. Together, we can continue to elevate our organization's quality standards and provide unparalleled value to our customers and stakeholders.
A Day In The Life Of Our Manager, Complaints and Post-Market
Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately
Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner
Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file
Manage adverse event reporting activities including decision rationale and reporting documentation.
Submit adverse event reports to regulatory authorities
Manage complaint metrics and analytics including trending and measure against statistical trend limits
Schedule post market surveillance reviews and complete post market surveillance reports based on applicable regulatory requirements
Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements
Initiate risk file updates based on post market data such as complaint rates and new hazards
Review customer inquiries and service reports for potential complaints
Identify and escalate complaints for potential adverse event reporting decisions
Perform complaint case final reviews for closure
Manage complaint handling team activities and provide guidance as needed
Review, revise and create SOPs (Standard Operating Procedures) and/or WIs(Work Instructions) related to complaint handling, adverse event reporting
Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements
Assist in audits (internal and external). May also conduct internal audits as needed.
Other QMS activities as assigned
About You
At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline.
5+ years of complaint-handling experience in the medical device industry.
Ability to manage others, their work, and your own multiple competing priorities.
Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments.
Strong Working knowledge of US FDA 21 CFR 820.198, 803, and 806 requirements.
Basic Working knowledge of OUS adverse event reporting requirements.
Basic Working knowledge of OUS post market surveillance requirements.
Working statistical knowledge as it pertains to trending Intermediate understanding of mechanical and software aspects of medical devices.
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Associate Key Account Manager - Boston, MA
Position Summary
As an Associate Key Account Manager, you will work side‑by‑side with a seasoned Key Account Manager to build a robust, qualified sales pipeline in your assigned territory. Your primary focus will be prospecting and early‑stage engagement of priority accounts, setting the foundation for downstream revenue generation. Success in this role is measured by pipeline —ultimately driving incremental system sales for the Key Account Manager and region..
Key Responsibilities
Prospecting & Qualification
Execute targeted outreach (in-person, email, phone, social) against an existing, prioritized account segmentation.
Conduct discovery conversations to qualify leads and identify decision‑maker(s).
Book a minimum of 10 meetings per week across hospitals, health systems, and specialty clinics.
Add 5+ new, qualified opportunities per quarter to the funnel.
Pipeline Development
Source and set 20+ additional qualified opportunities per year, supporting 2 or more incremental system sales.
Track and report progress in CRM on a weekly cadence.
Collaborate with Marketing to execute local mailers, digital campaigns, and other demand generating activities.
Clinical Validation Events
Coordinate and support logistics (invitations, materials, setup) for physician clinical validation sessions.
Secure participation of at least 3 physicians per quarter in hands‑on events.
Attend events alongside the Key Account Manager, gradually leading presentations and demos with increasing autonomy.
Team Collaboration
Partner with KAM, CSM and Sales Operations to prepare territory planning.
Work closely with the Clinical Sales team in the region to help find expansion opportunities from our existing sites.
Work with Clinical Education and Marketing to develop call scripts and event collateral.
Liaise with Service and Medical Education teams to understand installation timelines, training requirements, and best practices.
Help support key site validation activities.
Professional Development
Participate in regular ride‑alongs, coaching sessions, and sales training.
Build product and clinical knowledge to advance toward full Key Account Manager responsibilities.
Qualifications
Bachelor’s degree in Life Sciences, Business, Marketing, or related field.
1–3 years of healthcare, capital process or medical device sales experience (territory or inside sales preferred).
Demonstrated success in prospecting and lead generation, with a clear understanding of CRM tools (e.g., Salesforce).
Excellent verbal and written communication skills; polished presentation ability.
Highly organized, self‑motivated, and goal‑oriented.
Ability to travel up to 80% within the territory. - Boston, MA area
Strong interpersonal skills, with a collaborative mindset and thirst for continuous learning.
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