Sr. Quality Associate (Remote)

For over five-decades, North Coast Medical (NCM) has established itself as a global leader in the Occupational, Physical and Hand Therapy markets. We design, manufacture and distribute a broad range of industry-leading product lines. NCM’s four functional divisions services the needs domestic healthcare providers, consumers, dealers and international distributors. We are still family-owned, and our founders’ original core values of providing opportunities for customers and employees alike remain.

Our team of diverse people, unwaveringly committed to excellence in product development, procurement, delivery and customer service. We value the talents and abilities our employees bring to this company and we believe they are an integral part of what makes us competitive and successful. We don’t just accept difference – we celebrate it, we support it and we thrive on it for the benefits of our employees, our products and our community. We are proud to be an equal opportunity workplace.

NCM offers:
·         Competitive salaries
·         Excellent benefits (e.g. Medical / Dental / Vision / Life Insurance, PTO, 401k Match, Employee Assistance Program)
·         And the opportunity to work from home
 
North Coast Medical is looking for a Sr. Quality Associate. This position is remote and will report to the Quality & Regulatory Manager. See more details below!

Position Summary Overview: The Senior Quality Associate supports the execution and coordination of Quality Management System activities under the direction of Quality leadership. This role performs administrative and technical support functions related to document control, training management, quality event tracking, supplier controls, continuous improvement systems, and data compilation within the electronic Quality Management System. The position will also independently manage low-risk quality events and complaint records and is expected to progressively develop technical competency in investigations, regulatory requirements, and risk-based decision making as experience and proficiency increase to ensure audit readiness, process effectiveness, and records integrity.

Hours: Full Time, Non-Exempt

Compensation: $26.50/hr-$30/hr

Essential Functions and Position Responsibilities:

• Coordinate, track, and occasionally initiate routine quality events such as NCRs, deviations, and dispositions to support timely processing and closure.
• Assist with documentation, follow up on assigned action items, and ensure records are complete in accordance with established procedures. Accountable for adequacy of records.
• Manage defined low-risk complaint investigations including evaluation of available information, documentation of findings, and recommendation of next steps for Quality leadership review in compliance with 21 CFR 820.198.
• Prepare documentation, present records, and support timely resolution of findings for audits.
• Support supplier monitoring activities including review of evaluations, verification of documentation, and follow up on quality performance concerns.
• Identify workflow inefficiencies within quality system workflows and recommend improvements that align with processes while supporting lean practices.
• Coordinate status updates and reminders across departments to support closure of quality workflows and action items.
• Analyze routine quality performance metrics and escalate identified trends or anomalies to Quality leadership for evaluation.
• Act as coordinator and administrative workflow facilitator for QMS activities including document control routing, deviations, dispositions, training administration, audit scheduling, and action tracking.
• Maintain integrity and accuracy of quality records within the electronic Quality Management System in accordance with Good Documentation Practices and Document Control.
• Perform administrative duties related to product data upload, verification activities, and record retention.
• Provide support related to eQMS and procedures.
• Take ownership, exercise sound judgment, and drive work to completion with limited oversight, escalating appropriately when required.
• Other tasks as assigned by Quality leadership.

Position Requirements and Qualifications:

• Associate or Bachelor’s degree in a scientific, engineering, quality, or related discipline, or an equivalent combination of education and progressive experience in a regulated industry.
• Minimum 2 years of quality experience in a regulated environment (medical device preferred).
• Working knowledge of 21 CFR 820 and ISO 13485 requirements.
• Experience supporting internal and external audit execution, including follow-up activities.
• Proficiency in eQMS systems, document control, and record retention practices.
• Basic to intermediate Excel skills for data compilation, analysis, and reporting.
• ASQ or equivalent quality certification preferred.
• Experience with supplier monitoring and vendor quality oversight preferred.
• Experience drafting formal technical summaries and quality event documentation preferred.

Ability to:

• Demonstrate initiative through situational awareness, identifying tasks, and executing them accurately in accordance with established processes.
• Manage multiple tasks with accuracy and attention to detail.
• Manage assigned projects within defined authority parameters
• Present information and quality event outcomes clearly during trainings, meetings, and audits.
• Apply quality procedures and regulatory requirements in assigned tasks.
• Work independently on assigned tasks and collaborate within a team.
• Communicate effectively in writing and verbally.
• Maintain objective decision making, accuracy, and professionalism under deadline pressure.
• Manage multiple quality workflows and tasks while maintaining documentation accuracy and timelines.
• Escalate issues when risk triggers or uncertainties are identified.

Physical Requirements and Work Environment:

• This position is primarily remote but may require travel when and if required for certain job functions.
• Work involves sedentary to light work in a home office setting. There is frequent need to stand, stoop, walk, sit, lift light objects (up to 10 pounds) and perform other similar actions during the workday.
• Frequent speaking, listening, using a headset, sitting, use of hands/fingers across keyboard or mouse and extended periods of time working at a computer.
• High speed internet connection with full video conferencing capacity and bandwidth for VPN access.