Job Details

The SQE supports supplier change requests (SCRs) to enable product ramp?up for Lung Health at the Cheshire facility. The role works closely with suppliers and cross?functional teams to evaluate, coordinate, and implement supplier changes while maintaining quality and regulatory compliance. This individual is a self?starter who can track multiple timelines, drive alignment across functions, and help ensure changes are executed efficiently to support production needs.

 What are the top 3 things you are looking for in a candidates experience:

1. Experience supporting supplier change requests or supplier quality activities in a regulated manufacturing environment (medical device, pharma, or similar), including documentation and change control.
2. Ability to work cross?functionally with suppliers, engineering, operations, and quality teams to coordinate change implementation and resolve issues.
3. Strong project and timeline management skills with the ability to track multiple supplier changes and drive tasks to completion during production ramp?up

Education Required: Bachelors

Years’ Experience Required: 1-5 years

Responsibilities may include the following and other duties may be assigned.

Ensures that suppliers deliver quality parts, materials, and services.

Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation.

Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow the company to provide customers with the highest quality and reliable products.

Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.

Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.

Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation – while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Entry-level individual contributor on a project or work team.Works with close supervision.

Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.Makes minor changes in systems and processes to solve problems.

Communication and Influence: Communicates primarily with internal contacts within immediate group.Contacts others to gather, confirm and convey information.

Leadership and Talent Management: N / A – job at this level is focused on self-development.

Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)