Description

The Senior Manufacturing Quality Engineer is responsible for ensuring quality process and standards are in place and followed in the manufacture of RefleXion products.  This person will engage with the New Product Introduction team to ensure that processes and procedures developed for design transfer comply with and enable compliance and efficient operations.   The person will support equipment qualifications and process validation activities in manufacturing to meet quality standards and regulatory requirements.  This person represents the Quality Assurance function in manufacturing and will ensure that appropriate process controls are in place to ensure product conformity.

 Responsibilities                                                   

  • Develop and improve manufacturing and quality processes.
  • Facilitate design transfer for manufacturing activities from a quality perspective.
  • Participate in cross-functional reviews of pFMEAs.
  • Align manufacturing process instruction (MPI) and travelers with product/subsystems/system requirements and ensure that appropriate in process inspection steps are included.
  • Monitor product quality performance through manufacturing data such as yield, rework and NCR’s and by applying statistical process control (SPC) and CPK analysis of critical raw materials/parts and process parameters.
  • Participate in the selection of inspection equipment required to support tests necessary to support part/assemblies/product testing for both in process and product release activities.
  • Work with engineering team to develop methods and write detailed Quality Inspection Plans (QIP) for incoming inspection for parts/assemblies/materials.
  • Coordinate with engineering team to appropriately set the calibration requirements and preventive maintenance schedule for equipment/tools/fixtures.
  • Conduct and support IQ, OQ, PQ for equipment/tools/fixtures.
  • Design and conduct gage R&R (Range and Repeatability) studies.
  • Ensure continuous traceability from purchase order, to drawing, to PLM, to ERP system and that all traceability is documented, linked or captured in DHR.
  • Conduct root cause analysis using appropriate methods (e.g. 8-D Corrective & Preventive Action, Fishbone Diagrams, 5 Whys, DMAIC, etc.) and implement corrective actions for identified issues.
  • Coordinate and perform quality process audits for compliance with standards and regulations.
  • Report on level of systems compliance, areas requiring changes or improvements and recommend corrective actions and track and document related efforts and results.
  • Monitor findings for verification of effectiveness and ensure closure of related tasks.
  • Perform other duties as assigned.

Qualifications

  • BS Degree in Mechanical or Electrical Engineering (or equivalent experience)
  • ASQ Certifications (CQE, CMQ, SSGB, SSBB, CQA) a plus. 
  • Experience applying regulatory standards and process control measures to complex electromechanical capital equipment and related software.
  • Minimum three 5 years’ experience in manufacturing quality with a minimum of 7 years’ experience in a medical device design, manufacturing, or quality engineering capital equipment
  • Experience in manufacturing medical devices in conformance with FDA 820 Quality System Regulation, ISO 13485:2016, and ISO 14971:2012.

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at RefleXion Medical are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.