Senior Supplier Quality Engineer

Position Summary: *** This position is remote in Michigan. - Candidate will need to travel to Auburn Hills regularly.**** The Senior Supplier Quality Engineer will maintain quality assurance standards which adhere to Quality System Requirements (21 CFR 820), ISO regulations (ISO 13485) and other applicable regulations to ensure products and services are provided to customer requirements. This position is responsible for the quality and regulatory compliance of products manufactured at Suppliers and External Manufacturers.

Duties and Responsibilities: Under limited supervision and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

• Will monitor quality performance of suppliers and external manufacturer’s, implement inspection and test methods for assigned product lines manufactured at suppliers, where required participate in Technical assessments & quality system audits of suppliers to identify potential areas of risks, process variability and address root causes.
• Will perform process variability studies, Risk analysis, test method variability and establish sampling plans using valid statistical techniques
• Lead in the investigation of complex manufacturing product quality and compliance issues with assistance from appropriate SMEs (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop action plans. Will lead or support teams to investigate quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA
• Will provide support to develop and maintain good documentation to support the Validation Process, specifications, manufacturing and test procedures. Support and/or approve the preparation of validation and qualification protocols and support the execution of process / product qualifications &validations (IQ, OQ, PQ) projects with suppliers and external manufacturers.
• Will participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements. Supports in the identification and ensure the optimization of complex Manufacturing processes using engineering methods
• Will participate in preparation of Process/Design Failure Mode and Effects Analysis ( PFMEA / DFMEA)
• Will participate in new product development team activities in the development and qualification of suppliers
• Responsible for communicating business related issues or opportunities to next management level
• Performs other duties assigned as needed
  
  

Candidate will be required to travel globally for Supplier assessments, Quality Business Reviews and compliance audits.

Qualifications

Education: High School or Equivalent Associate’s Degree Bachelor’s Degree Master’s Degree PhD Degree Electrical Engineering (BSEE), Mechanical Engineering (BSME), Chemical Engineering (BSCE), BS Microbiology (BSc) or other related Engineering practices is required.

Years of Related Experience: ▪ 3-5 years of work experience (or equivalent) in the Medical Device industry, medical field or regulated environment, or in other applicable quality roles.

▪ Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations: (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

▪ Prior experience within an electro-mechanical or chemical environment as well as previous medical device experience is preferred.

▪ Prior knowledge of medical device regulations such as 21 CFR 820 and ISO 13485 are preferred.

▪ Experience with process validations and the use/application of statistical tools is preferred.

▪ Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts. Candidates who have prior experience in (sampling, design of experiments, process capability analysis) as well as the capability to review manufacturing processes (Control plan, process control and quality control) will be given higher considerations

▪ This position will have interactions with cross functional teams including but not limited to Supply chain, R&D Engineering, Operations Engineering, Manufacturing, Sourcing, other Quality departments and Regulatory

▪ This position may have interactions with Government agencies, third party registrars and Customers.

▪ This position will also be interacting with Components and External Suppliers.

Physical & Work Environment Requirements Physical Requirements: The physical demands identified are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. While performing the responsibilities of this job, the employee may be required to talk and hear. The employee is often required to sit and use their hands and fingers, to handle or feel. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop and kneel. Vision abilities required by this job include close vision.

Travel on the Job: Up to 30% ☒ Domestic ☒ International

Fortive Corporation Overview

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 17,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

About Advanced Sterilization Products

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.

Pay Range

The salary range for this position (in local currency) is 81,200.00 - 150,800.00

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.

The salary range for this position (in local currency) is 81,200.00 - 150,800.00