Participate in new
product/process teams to develop quality-engineered systems and products, support
design verification tests, process validations, quality processes to ensure compliance
with the company’s Quality System policies and procedures and applicable
external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and
other worldwide regulatory agencies, Johnson & Johnson Environmental,
Health & Safety Practices, and other applicable standards as pertains to
medical devices. Drive quality assurance
activities intended to ensure effective product quality processes are in place
and executed throughout lifecycle of product. May receive technical guidance on
complex problems, but independently determines and develops approaches and
solutions. Role will be located in Salt Lake City, Utah.
ESSENTIAL DUTIES AND
- Primary responsibilities include working
in Quality Operations or Quality Engineering and with other functional
groups in support of new product/process development.
- Utilizing Quality Engineering
tools/processes in development and implementation of practices for the
effective and efficient development, transfer, and maintenance of
products/processes throughout the product lifecycle.
- Develop and establish effective quality
control and associated risk management plans.
- Write, review and/or approve process and
product validation protocols and reports, equipment qualifications,
engineering change orders.
- Use statistical tools to analyze data,
make acceptance decisions, and improve process capability (Six Sigma, SPC,
- Direct Failure Mode and Effects Analysis
activities for both Design and Process FMEA’s.
- Provide all planning necessary to ensure
effective product acceptance. This
includes, but is not limited to, part qualifications, specification
development, and sampling plans.
- Support vendor audits as technical lead as
needed and support Supplier Quality as Quality Operations/Product Quality
representative as appropriate.
- Participate in MRB review of nonconforming
product; recommend disposition and corrective action.
- Initiate and investigate Corrective and
Preventative Actions (CAPA) as appropriate.
- Assist Regulatory Affairs in developing submissions
for process changes, inspection changes, and new processes/devices as
- Participate in design reviews and
pre-validation assessments to ensure the safe and environmentally sound
start-up of new processes.
the feasibility and soundness of proposed engineering evaluation tests,
products or equipment when necessary data are insufficient or confirmation by
testing is advisable.
- Responsible for communicating business related issues or
opportunities to next management level.
- Responsible for ensuring personal and Company compliance
with all Federal, State, local and Company regulations, policies, and
- Performs other duties assigned as needed.
EDUCATION/TRAINING and/or EXPERIENCE:
- Bachelor’s degree in a related field,
minimum of 2 years of quality, manufacturing, or research and development work
experience in a medical device or other regulated industry is required.
degree is preferred.
SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
- American Society for Quality (ASQ) certification, Six
Sigma experience, and/or knowledge of Process Excellence tools is desirable.
of GD&T (Geometric Dimensioning and Tolerancing) is desirable
to develop and implement Quality standards is preferred.
knowledge of Quality and operations systems and processes, including GMP and
QSR requirements for medical devices is preferred.
knowledge of leading edge Quality Engineering, design control, and verification
and validation (V&V) tools and methodologies is preferred.
to apply project management skills to ensure fulfillment of new product
development requirements is required.
problem solving skills is required.
understanding of theoretical and practical fundamentals and experimental
engineering techniques is preferred.
- Competent using MS Office (word,
excel, power point, outlook, etc.).
- Ability to multi-task and manage
multiple assignments in a time manner.
- Good verbal and written
- Strong interpersonal and
United States-Utah-Salt Lake CityOrganization
Coherex Medical, Inc. (6226)Job Function