Job Description
Job Description
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 continuousimprovementIntegrity : Commitment, accountability, and dedication to the highest ethical standardsCollaboration / Teamwork : Inclusion of Team Member regardless of geography, position, and product orserviceAction / Results : High energy, decisive planning, timely executionInnovation : Generation of new ideas from original thinkingCustomer Focus : Exceed customer expectations, quality of products, services, and experience always presentof mindEmotional Intelligence : Recognizes, understands, manages one’s own emotions and is able to influenceothers. A critical skill for pressure situationsAbility to be a self-starter, seek new and better methods, and work with minimum supervisionCapability 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 environmentDemonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire towinRequirements
QUALIFICATIONS
Education / Experience Required :
Bachelor's degree in electrical engineering or material science, technical science or equivalent combination ofeducation and directly relevant experience8+ years’ directly relevant experience, with prior experience in a FDA / cGMP or regulated environmentWorking knowledge of PPAP and IQ / OQ / PQ validation techniquesStrong written and verbal communication skillsDirect experience as a Manufacturing Engineer, Test Engineer, or Supplier Quality Engineer with the assignedcommoditiesHigh level Excel or other statistical software skills for data analysis, problem solving and reportingDeep expertise in high-level quality systems best practicesPreferred :
8+ years of experience in FDA / regulated environmentTeam leadership and project management experienceContract manufacturing support / PCBA manufacturing supportExperienced with six-sigma and lean manufacturing techniquesDirect experience working with injection molding, plastic film welding / bonding, over-molded cables, and / orWire harness assemblyAbility to translate quality improvements to cost savingsCertified quality auditorSUPERVISORY RESPONSIBILITIES :
None
WORK ENVIRONMENT :
Indoor open office environmentMinimal noise volume typical to an office environmentExtended / overtime hours when neededKestra manufactures and provides life-saving products regulated by the Federal Food and DrugAdministration and under contract with Medicare. Kestra maintains a drug free workplace and testing is acondition of employment.PHYSICAL DEMANDS
Frequent repetitive motions that may include wrists, hands and / or fingers, such as keyboard and mouseusageFrequent stationary position, often standing or sitting for prolonged periods of timeFrequent computer useFrequent phone and other business machine useOccasional lifting required, up to 20 poundsTRAVEL
Frequent travel is required, 10-15%
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.
Benefits
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.