Danaher Corporation Supplier Quality Manager in Solna, Sweden
Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna / Sundbyberg we develop and manufacture diagnostics tests that improve patient outcome all over the world. The Supplier Quality Engineering Manager is responsible for a team of Supplier Quality engineers that perform and manage a variety of supplier quality activities that are focused on the quality and compliance of supplied components, reagents, biologics, and contract manufacturers/OEMs to Cepheid. The SQE Manager will support New Product Introduction and Sustaining teams for the Solna, Sweden site as well as collaborate with the Sunnyvale, CA, USA headquarter site for global needs. The SQE Manager shall also provide leadership and guidance, not only to the SQE team in Solna, but also to cross-functional teams by developing positive relationships and interfacing with suppliers, engineering, and supply chain.
This position is part of the Quality Systems Department and will be located in Solna, Sweden. Our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role, you will have the opportunity to:
· Be able to mentor and lead a team of SQEs to understand, manage, and apply the manufacturing quality toolset including NCR/SCAR, Review Boards as applicable, PFMEA, IOPQ, GR&R/measurement system analysis, test method validations, control plans, process verification/validation plans, validation protocol development, Cpk/PpK, SPC, hard gauging applications, sample plan decisions, computer-based inspection methods, visual standards, operator work instructions, supplier control plan methodologies, supplier selection, DOE, process data analysis, supplier auditing, supplier agreements, and DMAIC/Continuous Improvement planning.
· Develop/Improve the supplier quality system procedures through cross-functional teamwork
· Manage and work with product support teams (NPI and Sustaining), supply chain, engineering and others on supplier quality issues, projects and initiatives
· Manage/Direct supplier interactions where and when needed
· Manage and assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution
· Review/Approve various forms of technical documentation created in the product lifecycle as well as supplier generated. This can include technical reports, phase gate reviews, design reviews, risk assessments, protocols, test plans, etc.
The essential requirements of the job include:
· Bachelor’s Degree in mechanical engineering, electrical engineering, industrial engineering or related discipline and a minimum of twelve (12) years related experience with a minimum of 5 years of Quality Engineering Management experience.
· Experience in the medical device industry - Knowledge of CFR 21 Part 820 (QSR) and ISO 13485 as well as representing their department during quality system audits (internal and external)
· Experience in the following supplier related activities: Corrective Action, Quality Agreements, Scorecarding, Auditing, Supplier/Part/Process Qualifications and Validations, GD&T, IOPQ, PFMEA, Gage R&R, Test Method Validations, PPAP/APQP methodologies, Supplier Change Notification, Statistics, Process Capability, and Application of Process Control management.
· Superior communication skills, both oral and written including presentations, interpersonal, organization, planning, prioritization, team building, and leadership. Able to foster an environment that values diversity and inclusion and able to build strong working relationships.
· Ability to constructively challenge concerns and engage in transparent conversations while being asked to identify, analyze and solve problems with minimal direction and make decisions with confidence. Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills).
· Able to review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerance (GD&T), proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Can recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Understands testing and mechanical evaluations.
It would be a plus if you also possess previous experience in:
· A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, CQA, Certified in Lean manufacturing and/or Six Sigma, etc.
· Global sites management experiences and collaboration with a matrix management structure
· Ability to work in an office environment and potentially audit manufacturing sites with travel to supplier sites approximately 25 percent of the time.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid