DePuy Synthes Companies of Johnson & Johnson
is recruiting for an Associate Quality
Assurance Engineer to be located in Elmira, NY.
DePuy Synthes Companies
of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic
and neurological business in the world. DePuy Synthes Companies will offer an
unparalleled breadth and depth of products, services and programs in the areas
of joint reconstruction, trauma, spine, sports medicine, neurological,
craniomaxillofacial, power tools and biomaterials. Building on the legacy and
strengths of two great companies, we are creating one organization that will be
agile and better equipped in today's evolving health care environment. With a
focus on activating insights to develop innovative, comprehensive solutions, we
are inspired to advance patient care in greater ways than either company could
accomplish on its own. The Associate Quality Assurance Engineer will:
- Develop, implement and
maintain Quality System requirements on assigned areas of manufacturing,
supplier management, and process validation.
- Areas of responsibility
may include: non-conforming product, CAPA, calibration systems, supplier
auditing, sterility assurance, and improving measuring techniques, design of
gages, training, statistical support, quality planning, experimental protocols,
and facilitation of root cause analysis, risk assessment and complaint investigation
- Know and follow all laws
and policies that apply to one’s job and maintain the highest levels of professionalism,
ethics and compliance at all times.
- Diligently participate
in our compliance program- related activities as denoted by your supervisor or
our Chief Compliance Officer
- Be a member of the
Material Review Board (MRB).
- Communicate and resolve
quality issues and apply root cause analysis to drive corrective and preventive
- Work on continuous
- These may include
participating in, and/or leading Quality Improvement Teams.
- Provide quality reports
and review trending on assigned areas of responsibility.
- Conduct failure
investigations and problem analysis regarding customer complaints, stock
evaluations, supplier quality issues, calibration out of tolerance conditions,
and CAPAs (internal or audit CAPAs).
- Review and approve
documents and drawings for manufacturing and product development (DCOs, MCs).
- Support to Engineering,
Manufacturing, Materials, Inspection, Distribution and/or Product Development
Groups in order to assure quality and compliance of products.
- Participate on cross-
functional project teams.
- Design gauging and
develop tools and techniques to measure product parameters to assure product
complies with engineering drawings.
- Recommend, acquire and
validate the necessary tools, equipment and technologies to support inspection
and testing activities.
- Develop and document
Quality Plans to support product acceptance activities.
- Facilitate creation of
risk management documents.
- Ensure compliance issues
are addressed for product activities.
- Participate on design
reviews and risk analysis for product changes.
- Provide process
validation program oversight to ensure adequacy of validation activities and
documentation in terms of regulatory compliance and technical/statistical
- Review, assess and
evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and
regulations, statistical validity and approval.
- Provide guidance to
others for the generation of clear, concise and defendable protocols and
- Assist in determination
of the need for validation.
- Generate and/or maintain
internal validation master plans as required.
- Manage process
monitoring activities including tracking, data collection and analysis,
corrective action, and reporting.
- Manage supplier validation
activities including supplier assessment, protocol development, and generation
of supplier validation master plan(s).
- Lead continuous
improvement activities for the validation program to ensure efficiency,
effectiveness and compliance.
- Coordinate and participate
on supplier audits and technical assessments.
- Assist purchasing with
identification and qualification of suppliers and alternate manufacturing
- Administrate Supplier
Management Program and measures effectiveness.
- Manage Supplier CAPA
activities including root cause analysis, definition of corrective actions and
verification of actions.
- Coordinate Quality Plans
and inspection/test methods between suppliers and Synthes.
- Visit suppliers for the
purpose of quality issues investigation and capability analysis.
- Assist purchasing in
resolution of supplier complaints.
- A Bachelors Degree
- A minimum of 1 year (professional, internship, co-op, etc.)
experience working in a quality system framework (ISO 9001 or similar)
- Medical device/diagnostic/or pharmaceutical industry experience
- Knowledge of FDA’s QSR and ISO regulations
- Working knowledge of Geometric Dimensioning and Tolerancing,
Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality
- Knowledge of Gage Repeatability and Reproducibility, Statistical
Process Control, Process Capability and Design of Experiments
- ASQ Certified Quality Engineer, Lean Manufacturing and/or Six
- Knowledge of Manufacturing materials and removal processes
(machining, sheet metal, electro polishing, passivation, hard coating,
cleaning, adonization, etc.)
- A minimum of an Associate’s degree in Sciences, Business,
Engineering or related technical field with experience in a highly regulated
- Ability to manage multiple projects/requirements in a fast-paced
- This position will be located in Elmira, NY and may require up to
10% travel including potential international travel.
United States-New York-HorseheadsOrganization
Depuy Orthopaedics. Inc. (6029)Job Function