Job Details: Quality Assurance, Additive Design Quality


JobsIreland
Jervis Street
Dublin 1
Quality Assurance, Additive Design Quality
Position:  Staff Quality Assurance, Additive Design Quality
ABOUT STRYKER

Stryker is one of the world&#**Apply on the website**;s leading
medical technology companies and, together with our customers, is
driven to make healthcare better.

_WE OFFER_ innovative products and services in Orthopaedics, Medical
and Surgical, and Neurotechnology and Spine that help improve patient
and hospital outcomes. We are proud to be named one of the
World&#**Apply on the website**;s Best Workplaces and a Best Workplace
for Diversity by Fortune Magazine. Learn more about our award-winning
organization by visiting STRYKER.COM

Who we want:

PATIENT-ORIENTED ACHIEVERS . Engineers with an unparalleled work ethic
and customer-focused attitude who bring value to their partnerships.

CHARISMATIC NETWORKERS . Relationship-savvy people who intentionally
make connections with both internal partners and external contacts.

CHALLENGERS & INFLUENCERS. People who constantly challenge themselves
and each other to achieve more & to win the right way.

TEAMMATES. Partners who listen to ideas, share thoughts and work
together to move the business forward.

What you will do:

As part of a newly formed team, you will be an integral part to
developing and launching innovative Additive Spine implants and
instruments. Being located in our new, global Additive Center of
excellence in Cork, Ireland, you will closely collaborate locally with
our Advanced Operations team, and internationally with our Spine
R&

D headquarter in Leesburg, US, to bring new products to the market and
value to our customers.

_YOU WILL_ be owning the quality aspects of key design control
documentation such as risk files and critical to quality product
features, be a key stakeholder in change management, as well as be an
integral part of developing and improving quality system components to
enable new business and improving existing workflows for our additive
portfolio. We are looking for a highly motivated, collaborative, and
accountable quality engineer who wants to embark with us on the
journey of building a new team, focusing on bringing innovative
additive products to our customers to make healthcare better.

RESPONSIBILITIES:

* Develop quality assurance documentation to support new product
development process and regulatory submissions.
* Lead quality system maintenance by identifying and correcting
deficiencies in procedures and practices.
* Mentorship of quality engineering team members, technical
ownership, development and improvement of quality processes.
* Partner with cross-functional project teams to lead product and/or
process design and development activities.
* Lead risk management activities for new product development
projects.
* Evaluate overall residual risk for products prior to launch and
present final risk/benefit justification to executive leadership.
* Present risks associated with the product use during Design Reviews
and track the design, documentation, and manufacturing process
mitigate those issues throughout the development process.
* Partner with cross-functional project teams to define design
verification and validation test requirements that ensure appropriate
objective evidence is available to support the acceptance criteria.
* Partner with Advanced Operations in the development of
manufacturing processes for new products.
* Utilize standard statistical analysis and problem-solving
techniques to determine product acceptance limits, establish process
parameters, resolve quality problems, etc.
* Develop, review, and approve inspection plans, routers, and product
drawings for new products.
* Support product design transfers to internal and/or external
manufacturing facilities.
* Provide support and direction for other Quality Engineers.
* Evaluate predicate products for relevant quality issues that may
impact new product development projects.
* Analyze and define critical quality attributes for product and
process through risk analysis techniques.
* Participate in collection of initial market feedback on new
products and address early concerns.
* Contribute to the completion of final design verification and
validation reports by providing concise conclusions with statistical
validity and graphical support.
* Lead investigation and health risk assessment for post-market
events.

What you need:

BASIC QUALIFICATIONS:

* Bachelor&#**Apply on the website**;s Degree in engineering or
science related field
* Minimum 5 years&#**Apply on the website**; experience in
engineering, quality, manufacturing, NPD or working in a highly
regulated industry

Preferred

QUALIFICATIONS:

* MS, CQE, or CRE preferred.
* Prefer experience with medical device product development
lifecycle, including risk management and design/process verification
and validation.
* Demonstrated applied knowledge of Advanced Quality tools such as
Failure Modes Effect Analysis (FMEA), GD&

T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
* Strong knowledge of Quality Concepts (e.g. CAPA, Audits,
Statistics).

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for
this position. LEARN MORE ABOUT OUR EMPLOYEE REFERRAL PROGRAM.


We need : English (Good)

Type: Permanent
Payment:
Category: Others

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