Director of Manufacturing-227316

2 weeks ago

Cleveland, United States Medix™ Full time

Job Title: Director of Manufacturing - IV Diagnostics

Location: Cleveland Ohio

Position Overview:

Become the first Director of Manufacturing for a growing IV Diagnostics company that has recently gained FDA approval for on site Manufacturing, to combine with their current use of CMOs. You would be establishing the SOPs and standards of the site and would lead the growth of the manufacturing.


Key Responsibilities:

  • Lead the manufacturing operations for our IV diagnostics product line, overseeing all aspects of production, including but not limited to assembly, testing, packaging, and distribution.
  • Develop and implement strategic plans to optimize manufacturing processes, improve efficiency, and enhance product quality while meeting production targets and cost objectives.
  • Establish and maintain robust quality management systems (QMS) in compliance with regulatory requirements, including FDA regulations, ISO 13485, and other applicable standards.
  • Drive continuous improvement initiatives across manufacturing operations, leveraging tools and methodologies such as lean manufacturing, Six Sigma, and process optimization techniques.
  • Collaborate closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, Supply Chain, and Sales, to ensure alignment of manufacturing activities with overall business objectives.
  • Provide leadership and guidance to manufacturing staff, fostering a culture of accountability, teamwork, and continuous learning.
  • Oversee supplier management and procurement processes to ensure a reliable supply of raw materials and components, effectively managing risks and optimizing costs.
  • Lead risk management activities related to manufacturing processes, product quality, and regulatory compliance, implementing proactive measures to mitigate potential risks.
  • Prepare for and participate in internal and external audits, regulatory inspections, and quality system assessments, ensuring readiness and compliance at all times.
  • Stay abreast of industry trends, regulatory updates, and emerging technologies in IV diagnostics manufacturing, incorporating best practices and innovations into manufacturing operations.

Qualifications:

  • Bachelor's degree in Engineering, Manufacturing, or related field required; Master's degree preferred.
  • Minimum of 5 years of experience in manufacturing leadership roles within the medical device industry, with a focus on Class III devices and IV diagnostics preferred.
  • In-depth knowledge of FDA regulations, ISO 13485, and other relevant quality and regulatory standards.
  • Strong leadership and management skills, with demonstrated experience leading cross-functional teams and driving organizational change.
  • Proven track record of implementing process improvements, cost-saving initiatives, and quality management systems in a manufacturing environment.
  • Excellent communication, interpersonal, and problem-solving skills, with the ability to effectively collaborate and influence stakeholders at all levels of the organization.
  • Results-oriented mindset with a focus on achieving operational excellence, meeting deadlines, and exceeding performance targets.
  • Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities and business needs.

Benefits:

  • 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
  • 100% Employer-paid Dental & Vision for entire family
  • No cost for employee coverage for Group Term Life, Short & Long Term Disability
  • 4% retirement contribution Employer match
  • Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
  • Paid Family Leave Program
  • Generous PTO plan & holiday program - 3 weeks vacation, 2 weeks of sick time, and 10 holidays
  • Flexible work schedule & lucrative employee referral program
  • Salary range may vary by work state/geographical region/territory
  • Easy to get to office location with newly built-out office space

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