The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life.
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:
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.
We are unable to sponsor or take over sponsorship of employment visas at this time. Applicants must be eligible to work for any employer in the U.S.
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.
Kestra Medical Technologies, Inc does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.
