Director Of Quality

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Job details:
Lead Quality at the Forefront of MedTech Innovation!!

This Jobot Job is hosted by: Chris Gorman
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and sending us your resume.
Salary: $200,000 - $230,000 per year


A bit about us:

We are a privately held medical device company dedicated to improving treatment options for patients suffering from an enlarged prostate. Our company’s innovative, minimally invasive technology was designed with the patient experience at the forefront, and our product has passed PMA review and is ready for commercial use!


Why join us?

What We Offer:

• Competitive base pay and equity
• Full benefits: Medical, Dental, Vision
• Generous PTO, vacation, sick, and holidays
• Life Insurance coverage
• 401K
• Free Lunch Friday
  
  
  

Job Details

Job Details:

We are seeking a dynamic and experienced Permanent Director of Quality to join our team in the Manufacturing industry. This role is critical to the success of our organization, as you will be responsible for leading and managing all aspects of our Quality Assurance program. You will be instrumental in ensuring that our products meet the highest standards of quality, safety, and efficacy. You will work closely with various departments, including production, engineering, and regulatory affairs, to ensure compliance with all relevant regulations and standards.

Responsibilities:

1. Overseeing the development and implementation of our Quality Assurance program, ensuring compliance with ISO 13485, FDA QSR, and EU MDD regulations.
2. Leading the quality team in the execution of quality assurance activities, including inspection, testing, and auditing of our products to ensure they meet all required specifications.
3. Collaborating with the engineering and production teams to ensure quality is built into our products from the ground up.
4. Managing the investigation and resolution of product quality issues, implementing corrective and preventive actions as necessary.
5. Leading the preparation and submission of regulatory filings, including 510k submissions for Class 3 Medical Devices.
6. Ensuring the commercial production of devices is in compliance with all relevant regulations and standards.
7. Providing leadership and guidance in the area of catheter manufacturing, ensuring the highest levels of quality and safety are maintained.

Qualifications:

1. A Bachelor’s degree in Engineering, Quality Assurance, or a related field.
2. A minimum of 5 years of experience in a supervisor quality role in the Med Device industry.
3. Demonstrated experience with Quality Assurance, ISO 13485, FDA, compliance, FDA QSR, and EU MDD.
4. Expertise in catheter manufacturing, commercial production devices, and 510k submissions is highly desirable.
5. Strong leadership and team management skills, with the ability to inspire and motivate a team to achieve high levels of performance.
6. Excellent problem-solving skills, with a proactive approach to identifying and resolving quality issues.
7. Strong communication and interpersonal skills, with the ability to effectively liaise with various departments and stakeholders.

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