Open Position : Sr Supplier Quality Engineer - Danvers, MA

Are you looking for professional growth opportunities as a full time
employee enjoying OUTSTANDING BENEFITS? Do you have 5+ years of
professional experience in the biotech/pharmaceutical industry? We
offer a rare opportunity to work within an organization where
individual contribution makes a significant difference.

Title : Sr Supplier Quality Engineer
Location : Danvers, MA

What You'll be Doing

You will be responsible for the assessment of purchased materials to
specified requirements and ensuring the control of nonconforming
product and compliance to FDA, international requirements and Quality
System Regulations.

Drive supplier quality oversight, monitoring and improvement
activities by use of supplier management strategies including audits,
quality/performance reviews and analysis of trend data.

Perform supplier product and process evaluations to identify areas for
improvement. Recommend solutions to identified problems.

Implement approved changes using sound quality engineering principles
and fully document them in compliance QBS, GMP and international
requirements

Provide comprehensive support to assigned cross-functional teams

Actively participate in definition of test requirements, justification
of acceptance limits and sampling plans to assure compliance with
Cardiovascular, corporate, FDA and international requirements.
Participate in resolution of quality issues by coordinating MRB
activity, as appropriate
Routinely review regular supplier inspection data and prepare
statistical and operational performance reports.
Must respond to audit observations with appropriate corrective actions
Must be able to understand and led Risk Analysis Teams
Participate actively in product and process start-ups.
Design and write protocol and implement process validation procedures
in accordance with QBS, FDA and international guidelines.

What You'll Need

* Bachelor's degree in engineering, science or math.
* Demonstrated working knowledge of -
Process validation
Design of experiments
Vendor and internal auditing
Statistical quality control
Bio compatibility
Protocol/report preparation and
Material review board.
* Working knowledge of
Quality System Regulation (QSR 21 CFR 820)
Canadian Medical Device Regulation (CMDR)
EU Medical Device Directive (EU MDD 93/42 EEC),
ISO 13485:2003
* Minimum five years quality assurance experience in a GMP environment/
highly regulated industry.
* Three to six years with a Masters of Science.
* PC skills, work processing, spreadsheets, project management, etc.
* Advance Statistical Knowledge and Application
* ASQ certification.
* Guide wire/guide catheter experience and familiarity with medical
device regulatory requirements.

How to Reply

The most effective way of communication is via email please forward us
your updated WORD FORMAT resume (Address, Contact number and email is
must) Please mention your best hourly rate, availability and visa
status. Any questions, do feel free to email us to
bob.harold DeleteThis @vernascientific.com