job_021815c: Quality Engineer, Consure Medical (New Delhi, India)

From: Kristin Burns <kristin.burns_at_stanford.edu>
Date: Wed, 18 Feb 2015 06:38:37 -0800

Quality Engineer, New Delhi, India

Consure Medical is an emerging medical device
company that develops novel solutions for the
management of discreet and sensitive healthcare
needs. Consure’s initial focus is on managing
fecal incontinence in bedridden patients. Through
our proprietary technology and expanding product
portfolio we offer patients a superior option to
conventional bowel management strategies.

As a quality engineer, you will collaborate in
advanced R&D, assist in setting up pilot
manufacturing of new products, the transfer of
these products to production, and sustain
operations. You will help develop and execute the
Quality plan for the entire product portfolio
while ensuring projects are conducted in
compliance with internal, customer, and
regulatory requirements. Work will include
interfacing with several other members of
Consure’s dynamic cross-functional team, as
well as working independently. We are looking for
someone who can completely take ownership of
several projects and see them through from bench-top to bed-side.

Key Responsibilities
    * Take ownership and compliance of company
wide quality policy, QMS and regulatory compliances.
    * Champion the Design Control process and
assist the project teams in developing novel
implantable and transient devices.
    * Manage development and maintenance of
product risk management files and Design History Files.
    * Oversee design verification, validation,
and setting of pilot manufacturing and transfer
of these products to production or to external contract manufacturer.
    * In collaboration with manufacturing teams
complete process and equipment validations
(IQ/OQ/PQ) as needed. Ensure that new processes
are robustly designed and meet safety, quality, and cost requirements.
    * Develop the overall QC architecture for
each product lines including first article
inspection, incoming and in-process inspections,
and lot release testing, including sampling strategy and test methods.
    * Accountable for project management aspects
of the CAPA, complying with CAPA process,
communicating with leaders within Business and Quality.
    * Participate in component and service
supplier evaluation and audits and work with
suppliers to ensure appropriate quality controls are implemented.
    * Apply GDP and GMP principles throughout the
operations process and identify and implement
best-in-class quality engineering practices and
guide team on efficient and effective application of design controls.

Relevant Experience
    * A minimum of a Bachelor's degree in an
engineering-related discipline is required.
    * A minimum 3 years of professional
experience in a medical device manufacturing and
product development environment.
    * A working knowledge of the FDA 21 CFR part
820 Quality System Regulation, ISO 13485, and the EU Medical Device Directive.
    * Must be skilled in the implementation of ISO 14971.
    * Familiar with test methods and standards
for the design, verification, and validation of
medical device products, including process
(IQ/OQ/PQ), biocompatibility, shelf-life, and packaging validation.
    * Experience in test plan development and root cause failure analysis.
    * Skilled in the application of statistical
methods, statistical process control, sampling
plans, gauge R&R, design of experiments, and reliability demonstration.
    * Excellent verbal and written communication
skills, especially technical report writing, are required.
    * Self-starter, independent, enthusiastic to
learn - ability to work effectively on project teams.

If you're interested, please send your CV to
<mailto:info_at_consuremedical.com>info_at_consuremedical.com.
Received on 2015-02-18 06:38:41