Product Quality Continuous Improvement Leader

Company: Danaher
Location: Logan
Posted on: June 5, 2021

Job Description:

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

This Continuous Improvement Leader position is a critical role that reports into the QA organization, which directly supports the operational activities for the Logan Life Sciences site. The role will report directly to the site QA Leader.

The focus of this QA Leadership role will be to drive product quality improvements. Including processes related to product development, design, and changes resulting from internal & external sources. This role will be closely engaged with site operations & closely involved in the customer feedback/complaint process & CAPA process. The role will be responsible for leading & coaching X-functional teams for quality processes, with a specific focus on product creation and change. This position will be actively engaged in Quality Reviews & influencing product care priorities. The role will need to represent the voice of the customer in Product Quality reviews ensuring changes and improvements are tracked and implemented in a robust and timely manner. This role requires extensive interactions with Customers, Site Operations, Product Managers, Operational Product Quality, Supplier Quality, Quality Control, Quality Engineering, and R&D. The role will be responsible for oversight of change processes and primary QA representative new process and product review. This position requires a highly organized, motivated and driven leader, with strong people skills and customer focused mindset.

Essential Responsibilities

• QA Leader of Change processes, new products, and qualifications.
• Coach/SME to X-functional members on change process & appropriate tools.
• Provide training and support to ensure robust qualification and change processes, issues and drive mitigations.
• Coach and mentor X-functional team members supporting the Customer Feedback/Complaint Handling Process & CAPA process.
• Drive Product Quality & Production Process Controls Improvement priorities.
• Monitor Product Quality improvement to ensure execution of actions including any resulting customer communications/interactions.
• Ensure escalations are driven & responded to in a timely manner
• Have expertise in Quality Risk Assessments
• Interface directly with customers and internal groups.
• Review and approve documentation supporting design, qualification, and changes
• Overseas and aligns the output of the Change Control Board to ensure cross functional alignment on issues and drive engagement.
• Continuously working to improve the process and ensure alignment to the needs of the customers with respect to their regulated requirements etc.

Who you are

• Bachelor's degree in engineering or quality/health sciences field; and/or minimum 7 years work experience in a Quality or Regulatory Assurance related field
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Demonstrated experience with problem solving tools.
• Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical.
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Direct experience of working with ISO 9001
• Identify and report any compliance gaps related to ISO 9001 requirements & agreed customer expectations.
• Basic understanding of materials, properties, manufacturing processes, and product assembly.
• Ability to read and interpret professional journals and technical procedures.
• Strong communication and writing skills for working with global manufacturing, marketing, and development teams.
• Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.

Desired Characteristics

• Product-specific knowledge in biomanufacturing Hardware & Software
• Advanced degree in Quality Assurance and/or Regulatory Affairs field
• Minimum 7 years' experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role
• Experience of cGMP requirements &/or ISO 13485
• Demonstrated program management or leadership skills
• Demonstrated experience at effectively communicating within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies (i.e 6 Sigma/DMAIC) & in-depth understanding of site level products & related processes
• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
• 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).
• Excellent interpersonal, organizational, and influencing skills
• Ability to analyze and process data, and draw the appropriate conclusions
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
• Ability to analyze and process data, and draw the appropriate conclusions

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 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.

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.

Keywords: Danaher, Logan , Product Quality Continuous Improvement Leader, Other , Logan, Utah