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Principal Design Quality Engineer-Risk Specialist Carlsbad United States,  

Medtronic (company)


Posted on : 19 April 2018

Project Description

principal quality Engineer ~ risk specialist
 
careers that change lives
impact patient outcomes.  come for a job, stay for a Career.
 
the minimally invasive therapies group strives to enable earlier diagnosis, better Treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. 
patient monitoring focuses on improving outcomes associated with Respiratory compromise, deep vein thrombosis, nutritional insufficiency, and Healthcare associated infections.
 
a day in the life
 
the principal quality Engineer  ~ risk specialist will develop and manage the process that establishes and maintains Quality Assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.
 
 
essential functions:
 
  •  mentor and Coach, design quality assuance, r&d in regulatory and industry best practices in Risk Management.
  • review and mentor all the standalone hazarad Analysis e.g  iia: issue impact assessment.
  • develop and maintain compliance policies supporting the ventilation Risk Management Quality System.
  • support rfai and interactions with worldwide compentent authorities & notified bodies.
  • drive qms & product continuous improvement through capa the process, capa investigations, capa & compliance audit trending of quality data streams.
  • provide expertise and guidance in interpreting governmental risk regulations, agency guidelines and internal policies to assure compliance.
  • evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. elevate issues to management, as appropriate.
  • lead process improvement projects and conduct Training with quality to improve risk processes the gbus overall Quality System compliance. 
  • assist with site Regulatory Compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations.
  • maintain working knowledge of existing and proposed domestic and international Medical Device regulations and guidance documents and their impact on medtronics Operations.
  • prepare management reports depicting trends and useful data for management review purposes.
  • support management during external inspections and participate in the management of external inspections as required.
  
department specific/non-essential functions:
  • adheres to the competencies and skills for the specified position as defined in the quality professional leveling matrix.
  • other duties as assigned with or without accommodation.
     
 
must have requirements:
 
 

Education / experience:
bs with 7+ years relevant experience
ms with 5+ years relevant experience
phd with 1+ years relevant experience
 
 
skills/qualifications:
Auditing experience to the 21cfr820.30, 21cfr820.100, iso13485, is0 14971:2012, cmdr and the Medical Device directive.
certified Training in risk manangement, ISO 14971:2012, ha, iia, design FMEA.
formal taining in capa compliance & investigation techniques.
comparative Statistical techniques & Sampling plans.
 
 
nice to have ~preferred skills/competencies:
previous experience working in a cross-functional team environment.
asq cqe, cqa, csqe and/or cre certification.
familiar with Statistical Software tools (minitab, stat graphics, statistica),
familiar with iec 60601 and product specific industry standards.
dfss / lean green belt or black belt
 
other skills:
computer literate and experience with pcs, networks, and Applications
some travel required

 
about medtronic
together, we can change Healthcare worldwide. at medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore Health and extend life.  we challenge ourselves and each other to make tomorrow better than yesterday. it is what makes this an exciting and rewarding place to be.
 
we want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. let’s work together to address universal Healthcare needs and improve patients’ lives. help us shape the future.
 
physical job requirements
the above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
 
the physical demands described within the day in the life section of this job description are representative of those that must be met by an Employee to successfully perform the essential functions of this job.  reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
eeo
it is the Policy of medtronic to provide equal employment opportunity (eeo) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. in addition, medtronic will provide reasonable accommodations for qualified individuals with disabilities.
 
this employer participates in the federal e-verify program to confirm the identity and employment authorization of all newly hired employees. for further information about the e-verify program, please click here: http://www.uscis.gov/e-verify/employees
 
 

Locations

Carlsbad, California, United States

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