6-8 years of relevant experience in Quality, Manufacturing and/or Engineering
Experience in regulated industries like medical devices or pharma
Direct experience in GMP environments
Proven cross-functional collaboration skills
Knowledge of FDA and ISO regulations
Strong communication skills for complex explanations
Continuous improvement mindset, with process efficiency focus
Responsibilities
Develop and implement Global Product Transfer processes
Ensure product quality during transfer projects
Collaborate with quality, R&D, and manufacturing teams
Maintain compliance with quality and regulatory requirements
Establish quality metrics for successful transfers
Execute and oversee policies for consistent outcomes
Deliver procedural updates for new products
Benefits
Comprehensive medical, dental, and vision insurance
401(k) with company match
Paid time off
Parental leave
Potential for performance-based bonuses
Full Job Description
PURPOSE AND SCOPE:
Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.
Ensure product quality is achieved at the receiving manufacturing site level during product transfer projects
Partner with CE vertical quality, R&D teams, plant quality and manufacturing teams (as appropriate) in the transfer of new products or site to site transfers between manufacturing sites.
Ensure transfer projects comply with all quality and regulatory requirements, have clearly defined quality planning, including site registration, defined pfmea at receiving sites, training requirements established, inspections plans defined, validation plans developed and any other requirements as defined.
Transfer reliable quality products into manufacturing through partnership with vertical value streams and manufacturing operations
Assist in establishing receiving site quality metrics for a successful product transfer (example; capability, complaint rates, all quality deliverables achieved)
Oversee and execute policies and procedures to ensure consistent outcomes
Develop and execute quality and validation plans
Deliver all required procedural updates associated with the addition of a new product at the receiving manufacturing facility
Ensure all transfer activities are in compliance with the quality system, FDA QSRs and ISO 13485.
Performs other related duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position requires approximately 30% travel.
SUPERVISION:
None
EDUCATION AND REQUIRED CREDENTIALS:
Bachelor's Degree; Advanced Degree desirable.
EXPERIENCE AND SKILLS:
6 - 8 years' of relevant experience in Quality, Manufacturing and/or Engineering discipline.
Medical device, pharma or other regulated industry (automotive PPAP experience a plus)
Engineering background
Direct experience in design and/or manufacturing of medical devices/pharma in a GMP environment
Proven track record in cross-functional collaboration
Knowledge of FDA, MDD/MDR regulation in medical device and pharma
Excellent communication skills with the ability to present and explain complex topics to multiple levels within the organization
Demonstrated practice of continuous improvement and designing efficiency into processes
Bilingual in Spanish- nice to have
If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.
About Fresenius Medical Care
Fresenius Medical Care is a German company specializing in the production of medical supplies, primarily to facilitate or aid renal dialysis. The company is a leading provider of products and services for people with chronic kidney failure. Fresenius Medical Care operates in more than 120 countries and has over 120,000 employees. The company's products and services are used to treat approximately 3.4 million patients worldwide. The company is committed to improving the quality of life of patients with kidney disease and to providing innovative products and services that meet the needs of patients and healthcare professionals.
