Sr Supplier Quality Engineer

The Senior Supplier Quality Engineer is responsible for working with our development team and external suppliers to deliver high quality, life-saving products; from development, through the life of the product. Manages all aspects of tier one and sub-tier supplier quality activities for assigned suppliers/ commodities; drives quality and process improvement at assigned suppliers/commodities. Assesses, monitors, and ensures the continued adequacy and effectiveness of the quality system for the assigned supplier base. Supports supplier selection, supplier process validation/controls, general supplier development. Reviews and approves inspection sampling plans for selection parts.

ESSENTIAL DUTIES

Leads new and existing supplier audits, selection, development, and supports supply chain team strategies

Participates in design reviews with development teams and suppliers to ensure manufacturable designs and

definition of critical-to-quality/process/function parameters for critical components/sub-systems

Manages supplier part/assembly qualifications using PFMEA/AQPQ/PPAP techniques

Manages supplier process validation plans, and reports using IQ/OQ/PQ validation techniques

Approves supplier test and inspection plans and procedures to ensure quality at the source

Maintains supplier key performance indicators (KPIs) to support supplier score cards, and drive

improvements.

Drives supplier quality MRB dispositions, root cause determination, and 8D corrective actions/supplier

corrective action requests (SCAR)

Utilizes six-sigma and lean manufacturing techniques to lead continuous improvement of supplier

performance working with supply chain and development teams

Acts as supplier primary technical contact working both independently and in teams to support company

objectives

Maintains 100% compliance to Kestra Medical Quality Management System

Responsible for technical project management of supplier Audit, PPAP, SCAR, and other deliverables to meet

internal deadlines, and achieve objectives

COMPETENCIES

Passion: Contagious excitement about the company – sense of urgency. Commitment to continuous

improvement

Integrity: Commitment, accountability, and dedication to the highest ethical standards

Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or

service

Action/Results: High energy, decisive planning, timely execution

Innovation: Generation of new ideas from original thinking

Customer Focus: Exceed customer expectations, quality of products, services, and experience always present

of mind

Emotional Intelligence: Recognizes, understands, manages one’s own emotions and is able to influence

others. A critical skill for pressure situations

Ability to be a self-starter, seek new and better methods, and work with minimum supervision

Capability to discern relevant facts and in turn, effectively resolve issues by making good decisions

(compliance, quality, integrity, ethics, and critical thinking ability)

Ability to be flexible in a fast-paced goal-oriented environment

Demonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win

QUALIFICATIONS

Education/Experience Required:

Bachelor's degree in electrical engineering or material science, technical science or equivalent combination of

education and directly relevant experience

8+ years’ directly relevant experience, with prior experience in a FDA/cGMP or regulated environment

Working knowledge of PPAP and IQ/OQ/PQ validation techniques

Strong written and verbal communication skills

Direct experience as a Manufacturing Engineer, Test Engineer, or Supplier Quality Engineer with the assigned

commodities

High level Excel or other statistical software skills for data analysis, problem solving and reporting

Deep expertise in high-level quality systems best practices

Preferred:

8+ years of experience in FDA/regulated environment

Team leadership and project management experience

Contract manufacturing support/ PCBA manufacturing support

Experienced with six-sigma and lean manufacturing techniques

Direct experience working with injection molding, plastic film welding/bonding, over-molded cables, and/or

Wire harness assembly

Ability to translate quality improvements to cost savings

Certified quality auditor

SUPERVISORY RESPONSIBILITIES:

None

WORK ENVIRONMENT:

Indoor open office environment

Minimal noise volume typical to an office environment

Extended/overtime hours when needed

Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug

Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a

condition of employment.

PHYSICAL DEMANDS

Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse

usage

Frequent stationary position, often standing or sitting for prolonged periods of time

Frequent computer use

Frequent phone and other business machine use

Occasional lifting required, up to 20 pounds

TRAVEL

Frequent travel is required, 20%-30%

OTHER DUTIES:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change or new ones may be assigned at any time with or without notice.

Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.

Pay equity is an important part of Kestra’s Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Each role is benchmarked based on the job description provided If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted.

Salary: Annualized at $140,000 - $150,000, plus bonus. Depending on experience.Kestra Medical Technologies is an equal opportunity employer. Kestra Medical Technologies does not discriminate on the basis of race, color, religion, national origin, veteran status, age, sexual orientation, gender identity and/or expression, marital status, disability, physical or mental status or any other characteristic protected by law.