Danaher Corporation Senior Quality Project Engineer in Duncan, South Carolina
Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.
Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Senior Quality Project Engineer is a key player in the Quality Team. He/she will manage quality related processes with subcontractors who manufacture Pall product and manage customer queries related to Biotech expansion plans. He/She will also support expansion plans in existing or new Biotech manufacturing sites. He/She acts as a partner with suppliers, customers and manufacturing sites with members of all departments such as Operations, Sales, Purchasing, Strategic Sourcing, Engineering & R&D teams.
Represent Quality in Biotech expansion plans within your region and own quality related actions
Enable root-cause investigation at subcontractors, drive to root-cause and manage the implementation of CAPA’s
Facilitate FARA discussions and coordinate customer communications
Ensure that all products, processes, methods and equipment are validated and remain in validated state
Follow-up on the overall product quality of the subcontractors
Responsible to perform technical and Quality Management Systems based subcontractor audits
Support in subcontractor qualification and onboarding process; Responsible to supervise, improve and develop subcontractors
Customer Advocate / Voice of the Customer; Ensure alignment with customer requirements, where possible
Build and sustain positive relationships with Strategic and Key customers
Master’s degree in a scientific field, preferable in Lifesciences (Bio, Biomedical, Chemical, Pharma)
A minimum of 5 years of relevant experience
Experience in Project Management
Knowledge of ISO9001:2015
Knowledge of ISO11137, ISO14644 and ISO14698, preferred
Lean Six Sigma knowledge, preferred (Green/Brown Belt)
Strong working knowledge of quality assurance principles and practices, industry and international regulations and standards
Proven track record in leadership, both direct as well as cross functional
Knowledgeable in MS Office and statistical programs
Ability to travel up to 25-40% of your time, both domestically as well as internationally
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 tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
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.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or firstname.lastname@example.org to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.