Job Summary:
The Principal Quality Engineer is responsible for supporting all quality engineering activities to
support the product life cycle, from development of new products (NPD) from concept through
commercialization, through sustaining changes, as part of a cross-functional development team.
This includes active participation in origination of design concepts, design specifications, design
for quality and manufacturing requirements, process/technology development, product
verification/validation, project planning, and applicable documentation. Responsible for all
aspects (product and process) related to the quality of the designated product line(s). This
includes manufacturability of products, supplier manufacturing, and investigation of customer
complaints. Develops, modifies, applies and maintains quality standards, and generates
protocols and reports. The Principal QE provides coaching to Design Engineers and
Manufacturing personnel on Quality System Requirements and process improvement
methodologies for their product families.
Duties/Essential Job Functions:
- Independent self starter who is capable of planning schedules, control plans and leading
projects as assigned, who is able to incorporate FDA, ASTM and ISO standards through
the product life cycle, designing and developing the required inspection and process
control methodologies
- Provide authoritative guidance about Six Sigma principles (Sampling, Acceptance
Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts,
capability analysis) as well as guidance on Design Control elements to New Product
Development team members and Manufacturing Staff
- Develop and execute verification and validation plans and protocols associated with
product/process quality according to FDA and ISO regulations and our clients SOPs.
- Ability to manage multiple projects simultaneously without supervision. This includes
creating detailed and accurate project tasks and schedules, interfacing with project team
members and other support personnel and solving project-related conflicts and issues.
- Support supplier audits to ensure supplier capability including reconciliation of
inspection methods, and evaluation of proposed vendor changes for NPD and sustaining
activities
- Reviews ECN’s to ensure compliance to Quality System, QSR and International
requirements for New Product Development (NPD) and Sustaining activities
- Support person for Design History File during 3
rd
party inspections
- Estimate and gather necessary information on timelines and cost related to QA/QC tasks
for Project Planning? Perform hazard and risk analysis for new products and sustaining products, including
DFMEA and PFMEA
- Perform investigations for issues affecting product quality post-launch.
- Act as liaison between QC and project engineers to ensure that inspection process
capabilities have been verified and appropriately documented
- Other responsibilities assigned by supervisor and including vendor site audits, attending
surgeries and general corporate functions associated with role as Quality Engineering
professional
Experience/Skills Required:
- 7 – 9 years work experience in a Quality Engineering role, in the implantable medical
device industry, with a history of successful participation in New Product
Development (NPD) teams.
- Strong working knowledge of Design Controls, manufacturing process controls
- Understanding of human factors engineering
- Proficient in GD&T and metrology. Able to read detailed blueprints and follow
assembly instructions, develop inspection plans and evaluate CMM programs. Gage
R&R preferred.
- Ability to use metrology and statistical methods to diagnose and correct improper
quality control practices, with experience in CMM Programming, GD&T, Gage R&R
and Inspection Plan development
- Demonstrated successful application of analytical quality tools including Six Sigma,
Lean, SPC. DFSS training preferred
- Computer literate in various software applications. (i.e. - Word, Excel, Access,
Minitab.) Solidworks experience preferred
- Independent organization and prioritization of multiple tasks
- Able to lead DFMEA and PFMEA sessions as required
- Communication: Ability to internally and externally discuss and clearly define key
technical and process development issues and independently develop course of
action/plans
- Strong technical writing skills and ability to create technical protocols and reports as
well as manufacturing/inspection procedures
- Interpersonal: Ability to cooperate and support team members and ability to
coordinate interdepartmental activities and to resolve individual conflicts and issues.
- Business Acumen: Require a basic understanding of business and financial impact
of project.
- Teamwork: Pursue trust for each team member. Seek and deliver honest feedback
to all team members. Committed and accountable to achieving team goals. Abide by
team decisions
Required Education/Licensing/Certification:
- Bachelor of Science (B.S.) degree in Biomedical or Mechanical Engineering with a
minimum of nine (9) years of experience in the medical device industry, or
- MS degree in Biomedical or Mechanical Engineering with a minimum of seven (7) years
of experience in the medical device industry.
- Experience in Lean, Six Sigma and Process Validation/Process Capability
- ASQ CQE/CSSBB or equivalent preferred