Director of Quality

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Job Category

QA - Quality Control

Job Level

Manager

Job Type

Full time

Job Location

US, Santa Rosa, CA

Job Description

The purpose of this position is to improve and maintain the Quality Management System and strategies for maintaining compliance with established standards and agency guidelines.

 

Summary of Responsibilities:

Assist the VP of QA/RA in developing and implementing quality strategies. Act as a Management Representative and improve quality system / procedures to maintain compliance with ISO 13485:2003. Coordinate and lead internal and external audit. Maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements, and business process improvement initiatives. Support product registration and regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets, typically for Class I and II products.

 

Key Responsibilities:

  • Act as Management Representative for the company if it is required by the company.
  • Oversee generation and review of documents used in good manufacturing practices; monitor audits of production and quality control areas.
  • Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
  • Create Installation Qualification, Operational Qualification and Performance Qualification protocol and reports.
  • Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
  • Manage non conformance, corrective action preventive actions and deviation.
  • Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organizations.
  • Support product’s registration and regulatory submissions, including FDA 510(k), Technical Files, Canadian Device License Applications, and internal "Letters to File".
  • Review 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 and approve test protocols to support regulatory submissions.
  • Oversee Risk Management and provide input in design verification, design validation, shelf life studies.
  • Develop and implement departmental and divisional policies and procedures.
  • Supervise direct reports
  • Other duties as assigned
 

Skills & Requirements

  • Proficient in timely review of technical and clinical data.
  • Proficient in FDA and international regulations (EU and Canada)
  • Excellent managerial and organizational skills and abilities.
  • Strong leadership and motivational skills with effective team building capabilities.
  • Technical knowledge of medical devices.
  • Good presentation skills.
  • Excellent computer skills – proficiency with MS Office products 
  • Strong written and oral communications skills; strong technical writing skills.
  • Detail oriented and self-motivated.
  • Ability to write clear, concise, and well thought out technical documents.
  • Able to manage moderately complex problems/projects by exercising independent decision making and analytical thinking skills
  • Ability to work under minimal supervision and independently.
  • Must be able to work in a timeline-driven environment

 

Knowledge and Education:

  • Bachelor of Science in Mechanical Engineering; preferred Masters degree.
  • Knowledge of FDA medical device regulations, guidance, and import/exports requirements.
  • Knowledge of European Medical Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.)
  • Knowledge with medical device labeling and promotional requirements.
  • Strong understanding of the quality system and ISO13485 regulations
  • Demonstrated success in Quality management.
  • Knowledge or experience in Risk management
  • Knowledge of QS regulations preferred.
  • Statistical analysis and problem-solving ability strongly preferred

 

Benefits:

NeilMed offers Health, Dental, and Vision Coverage, we also have 401K plans and Life Insurance.  Vacation, Holiday and Sick Leave are all included in the first full year of employment. 

 

How to Apply

1. Email your resume to jobs@neilmed.com and include the job title in the subject line of the email

2. Any questions or for more information please text or call #707.530.5256



About Company

NeilMed Pharmaceuticals is a leading manufacturer in nasal saline OTC products. We are committed to providing exceptional customer service and satisfaction. We ensure that our products meet the highest level of quality and safety standards. We are always looking for experienced, self motivated, hard working, and dependable individuals to join our rapidly growing company. Qualification requirements will vary depending upon the job you are applying for. We offer competitive salary and benefits.

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