Director of Operations and Supplier Quality
Job Description
Description
Director of Operations and Supplier Quality
Category: QA – Quality Control
Position: Full Time
Home » Director of Operations and Supplier Quality
COMPANY PROFILE
Ketan C. Mehta, MD and Nina Mehta, founded NeilMed Pharmaceuticals, Inc. in January 2000 from Dr. Mehta’s medical office and in a short span, we have over 500 employees. NeilMed is the largest manufacturer and supplier of LVLP (Large Volume Low Pressure) saline nasal irrigation systems in the world.
The NeilMed brand of products help alleviate common nasal and sinus symptoms in a simple, safe, effective and affordable way. The company supplies millions of products to end users through various trade channels. Our headquarters & manufacturing facility is based in Santa Rosa, California, USA. In addition to our USA headquarters, we also supply and have offices in multiple countriesworldwide . Our unique business model has been a very strict vertical integration, for achieving precision and fast execution at all levels. NeilMed prides itself in being part of the small community of Santa Rosa, located in the heart of Sonoma County’s wine country in Northern California.
Our flagship products are NeilMedSINUS RINSE and NeilMedNasaFlo Neti Pot . These products are available in most stores in the USA, Canada, and several other countries around the world. There are currently over 40 different products for nasal and sinus care, and all are OTC (over the counter). With an extremely dedicated small team of loyal, and hard working leadership group, NeilMed continues to formulate innovative ideas to market. Additional diversification plans include the introduction of surgical devices for hospitals and emergency rooms. NeilMed supports medical research in several countries and educating health care professionals and consumers. We believe in excellent 24 hour customer service, helping local communities, and donating for natural disasters.
OUR MISSION
The mission of our company is safety and affordability to sustain long-term growth, creating drug free and effective nasal / sinus care products for millions of consumers worldwide.
Job Description
The Director of Operations and Supplier Quality will oversee the quality systems and standards for the organization, ensuring that all products meet regulatory requirements and internal specifications. This leadership role is critical to maintaining our commitment to excellence and compliance throughout the product lifecycle. This position aims to monitor and improve a quality management system, maintaining compliance with established standards and agency guidelines.
Job Experience
- At least 10 years of experience in the medical industry as a Director or Senior Manager of Quality Assurance.
- At least 10 years of experience managing/leading a team.
- Demonstrated success in Quality Management.
- Demonstrated management skills and experience.
- Experience developing a team and individuals
- Knowledge of or experience in Risk management.
- Knowledge of QS regulations preferred.
- Statistical analysis and problem-solving abilities are strongly preferred.
- Demonstrate extensive experience with the FDA, ISO 13485, and Notified Body inspections
SUMMARY OF RESPONSIBILITIES:
Act as a Management Representative, as needed. Implement the necessary changes in the quality system for improvements and maintain compliance with established standards. Maintain quality assurance programs, policies, processes, procedures, and controls, ensuring that the performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements and business process improvement initiatives. Responsible for providing adequate support for creating and preparing documentation that is required by the regulatory department for global registration submissions and approvals to introduce new products in the US, EU, Canada, Australia, and other jurisdictions for Class I, II devices, NHPs, and drugs.
KEY RESPONSIBILITIES:
- Act as a Management Representative, as necessary.
- Report to VP of QA/RA and Mfg.
- Be responsible for the performance of the quality management system and address any need for improvement.
- Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
- Oversee generation and review of documents used in good manufacturing practices and monitor audits of production and quality control areas. Provide expertise and guidance in interpreting governmental Quality regulations, agency guidelines, and internal policies to ensure compliance and effectiveness.
- Manage document control and oversee related quality systems such as training and other electronic quality systems to ensure effectiveness.
- Participate with peers in formulating overall direction, processes, systems, and talent development for the QA organizations.
- Provide adequate support for document preparation for global regulatory submissions, including but not limited to the FDA 510(k), technical documentation for medical devices and dossiers for drugs, Canadian medical device, NHP and drug license applications, internal “Letters to File”, etc.
- Assess device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
- Review and sign off on product and manufacturing changes for compliance with applicable regulations.
- Review, assess, and approve product documents, including but not limited to the design and manufacturing changes and labeling.
- Review and approve test protocols to support regulatory submissions.
- Oversee Risk Management and provide input in design verification, design validation and shelf-life studies.
- Provide technical guidance and training / mentoring to other QA employees and cross-functional teams.
- Develop and implement departmental goals, policies, and procedures.
- Monitor industry trends and regulatory changes to ensure that company practices remain compliant and competitive.
- Other duties as assigned.
Skills & Requirements
- Proficient in timely review of technical and clinical data.
- Proficient in FDA and international regulations (e.g., EU and Canada)
- Technical knowledge of medical devices (class I and II) and drugs.
- Ability to write clear, concise, and well-thought-out technical documents.
- Ability to perform well in stressful or time-sensitive situations
- Able to manage complex problems/projects by exercising independent decision-making and analytical thinking skills, with minimal supervision
- Strong leadership, organizational, interpersonal, and influencing skills
- Strong written and oral communication skills
- Detail-oriented and self-motivated.
- Ability to work well with team members and clients
- Ability to exercise judgment in selecting innovative, practical methods to achieve problem resolution.
- Ability to work under minimal supervision and independently.
- Must be able to deliver high-quality work in a tight-timeline-driven environment.
- Strong leadership, interpersonal and influencing skills.
- Ability to be flexible and adjust to changing circumstances.
- This is a full-time, on-site role based in our Santa Rosa Headquarters. Must be available to work 5 days per week, one Saturday per month and as needed per business requirements.
- Competitive salary bonus potential
- Relocation support as needed
- Health benefits including medical, dental and vision coverage for employee and family
- 401(k) with 4% match
- 6 paid holidays
1.) Do you now or will you in the future require sponsorship to work in the United States?
Yes No
2.) Do you hold a bachelor’s degree in science?
Yes No
3.) Are you within commuting distance or willing to relocate to Santa Rosa as this is a full-time, on-site position?
Yes No
4.) Have you successfully built and led a high-performing quality assurance team?
Yes No
5.) Do you have extensive experience with the FDA, ISO 13485, and Notifi ed Body inspections?
Yes No
6.) Do you have knowledge of FDA medical device and drug regulations, guidance, and import/export requirements?
Yes No
7.) Do you have knowledge of the European Medical Device Directive (MDD) and Medical Device Reporting (MDR)?
Yes No
8.) Have you developed and implemented a comprehensive quality assurance strategy in your previous roles?
Yes No
9.) Do you have at least 10 years of experience in the medical device and drug industry as a Director or Senior Manager of Quality Assurance?
Yes No
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Company
NeilMed Pharmaceuticals
Location
, , Canada
Country
Canada
Salary
100.000
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