Danaher Corporation Quality Assurance (QA) Investigation Lead in Shrewsbury, Massachusetts
Be part of something altogether life-changing
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva 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.
What you’ll do
Acts as QA lead for non-conformance investigations related to product quality complaints by executing root cause analysis investigations and determining appropriate corrective/preventative actions as a result of investigation findings
Uses 5-WHY, Ishikawa Diagram and other root cause tools to structure and lead problem solving activities within a cross-functional team; act as a project manager for those activities; develop countermeasures for identified root causes and contributing factors; understand and monitor effectiveness of countermeasures
Uses GEMBA tools to understand products and processes in order to evaluate potential root causes for reported complaint failures and execute on corrective actions
Trends failure modes and emerging issues, employs statistical analysis, and structures and organizes data across various product groups around failure mode signals
Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust completion of investigations; responsible for documentation of objective evidence in QMS records such as root cause methodology, technical reports, scientific data from experiments and sample evaluations in QMS records
Meets investigation timelines for non-conformance and CAPA items per procedure
Facilitates risk-assessment activities and acts as QA lead for Field Actions; drafts customer notification letters and supports field modification activities
Writes technical reports and investigation/CAPA memos which are communicated to customers
Supports customer visits and site audits as Subject Matter Expert from a root cause analysis, investigations/CAPA, and complaint handling unit perspective
Produces high-quality documentation that meets all applicable standards, both according industry best-practices and according to internal work instructions, and is appropriate for the intended audience
Works with CHU (complaint handling unit) leads in close conjunction to support correct documentation in QMS systems related to complaints and investigations
Develops process improvement strategies and supports execution of site/team continuous improvement goals and projects
Supports the QMS Internal Audit program and External Audits
Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required
Aware of and complies with the company Quality Management System, Quality Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Completes all planned EHS and Quality & Compliance training within the defined timelines
Who you are
Bachelor’s degree required; additional training/education preferred through ASQ (or relevant society) and/or Master’s level program
At least 5 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required; 6-10 years preferred
At least 3 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.) required; 4-6 years preferred
Experience working with cGMP and/or ISO 13485 environment with relation to investigations, as well as documentation, audit, and post market surveillance activities
Demonstrated expertise in problem solving (prefer accredited training such as Six Sigma, ASQ, etc)
Demonstrated background in core QMS concepts, QMS architecture, QMS improvement activities
Demonstrated background involving aspects of data-analytics
Demonstrated experience prioritizing conflicting demands in a fast-paced environment
Demonstrated time management skills
Ability to work independently and in a team setting
Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing)
Ability to deliver high quality documentation, paying attention to detail
Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio
Excellent interpersonal, organizational, and influencing skills, as well as presentation skills
Ability to analyze and process data with various statistical tools, and draw relevant conclusions
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Who we are
When you join us, you’ll also be joining Danaher’s global organization, where 68,000 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 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.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
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.
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