Description
FLSA Status: Exempt
Job is a direct hire/perm position located in San Diego CA. Work arrangement is hybrid with candidates needing to commute to the San Diego office of ICU Medical 2 days a week.
Position Summary
Under the general guidance of the Director, Quality Engineering, this Senior Manager, Quality Engineering-Device Software position manages the Quality activities related to ICU Medical Device Software Development, Testing, and Release, within Device Engineering and the Corporation assuring that proper systems and controls are instituted and maintained concerning all facets of process/product design, testing and release. The Quality Manager will be the San Diego ICU Medical function Management Representative in accordance with established Corporate Quality standards and Regulatory requirements.
Essential Duties & Responsibilities
·Perform the general management functions inherent to the position.
·Develop, establish, and coordinate Quality policies and procedures to assure that all software products designed, tested, and released by these sites conform to ISO 13485, IEC 62304 and ISO 14971 and corporate policies and guidelines.
·Assure that all sites and processes employed maintain conformance to established Corporate and Regulatory procedures and requirements.
·Provide recommendations on corporate policies and procedures to optimize quality and increase economic efficiencies.
·Maintain cooperative relationships with all departments within the function. The major interaction occurs with Quality and R&D. These relationships include:
oPartner with the R&D staff to develop and maintain development, testing, and release processes to assure compliance with procedures, specifications, standards, and regulatory requirements while maintaining a profitable operation.
oPartner with the R&D staff and others as appropriate to improve software development and release times while continuously improving the quality of the product.
oPartner with the Corporate Regulatory Affairs to assure safety, quality, and regulatory compliance of processes and products.
oPartner with Corporate Quality, R&D and others as required to develop and execute on the Quality Strategic plan
Knowledge, Skills & Qualifications
·Broad management experience across several functional areas or businesses or concentrated knowledge of a particular discipline; considered the organization's expert within a particular discipline
·Working knowledge of Medical Device Regulations
·Quality compliance, audit, and investigation skills
·Management skills and experience
·Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc)
·Demonstrated experience with ISO, GxP, FDA or other key regulatory bodies
·Able to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)
·Proven ability to work closely with Management level issues
Education and Experience
·Must be at least 18 years of age
·Bachelor's degree in software engineering or related engineering from an accredited college or university is required.
·10 + years of experience in quality, product design or product engineering
·5+ years of supervisory experience
Physical Requirements and Work Environment
·This is largely a sedentary role.
·This job operates in a professional office environment and routinely uses standard office equipment.
·Typically requires travel 5% to 10% of the time
Pay range: $124K-166,625K annually.
The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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