Quality Manager - New Product Development
Job Type: Full time
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Creganna Medical is part of TE Connectivity and is ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia. http://www.creganna.com/
The Quality Manager within the Devices business of TE Medical and in the new product development area will play an important role within the New Product Development team. The individual will guide teams to ensure that manufacturing processes are developed that meet both what the customer needs, as well as developed in accordance with local site development QMS expectations in turn aligned with regulatory requirements expected of a medical devices manufacturing organization.
The quality manager in New Product Development group will be the quality compliance expertise in the NPD group, and responsible for guiding to the overall NPD project delivery model as well as project teams themselves in areas of:
- Guiding a compliance and quality focus in the development of new products in the Devices business across the various sites within TE Medical.
- Guide the Quality input to NPD project planning through development phases in accordance with industry regulatory standards (ISO13485:2016 and 21CFR820)
- Guiding and mentoring a quality team within NPD and collaborating with peer functions
- Ensuring that project team are guided in maintaining project to the QMS requirements as they are achieving the customer design and performance expectations.
- That the new product development project is effectively planned, that is considers all applicable quality and regulatory for design and development planning and a successful project completion.
- Provide the guidance for the NPD Project teams, to maintain project development activity in accordance with requirements of ISO13485:2016, and 21CFR820 for design and development controls.
- Support the design control assurance objectives of the project team and the customer, to deliver on the required design history file elements in the phase of product and process development.
- Ensuring that project can be transferred to a commercial manufacturing scale with appropriate risk management applied within its development and for continued manufacturing.
- Apply best practice and proactive quality engineering principles to both the product and process development activity of within the NPD team.
- Manage the NPD Quality supporting team that are supporting the Devices business and activity in different sites.
What your background should look like:
- Bachelor's degree in Engineering or Science
- 8+ years’ experience in medical devices, with minimum 3 years in leadership roles
- Previous medical devices in support of development or operations manufacturing experience in a medical devices industry certified QMS environment is essential.
- Experience in a similar manager role involving new product development is a distinct advantage
- Ability to apply a structured problem-solving approach and Six Sigma tools and familiarity with these methodologies
- A Six Sigma certification (Green/Black) is an advantage
- Proficient in technical communication, and with a strong attention to detail is necessary
- Experience in customer interaction, and involving quality and technical focused collaboration, that can establish customer expectations, and while also to resolve customer design and manufacturing challenges is a distinct advantage in the role
ABOUT TE CONNECTIVITY
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
- Competitive base salary commensurate with experience: $112,600 - $169,000 (subject to change dependent on physical location)
- Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
- Total Compensation = Base Salary + Incentive(s) + Benefits
- A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.
EOE, Including Disability/Vets