Quality Engineer Manager (Consumables)
Location: San Clemente
Posted on: May 31, 2019
Quality Engineer Manager (Consumables)
If you are a Quality Engineer Manager with experience, please read
We are a Medical Device company who primarily develops,
manufactures, and sells medical technologies used in vascular
therapy, oncology, and critical care applications. We are looking
for our next great leader!
Our IDEAL candidate has medical device, consumables, has supervised
a team of engineers, has an Engineering degree, and will be able to
write design controls for any product we offer.
The Quality Engineer Manager ensures product development and
utilizes appropriate engineering and scientific analyses during the
product development and commercialization. They will work directly
with Quality Engineers to provide guidance and direction relating
to pipeline and on-market product development teams. This
individual will be responsible for implementation and maintenance
of the company's Quality System /Medical Device standards to ensure
compliant, safe and effective products. Will manage new product
offerings and product life cycle management by assuring adequate
completion of Qualification activities, compliance with our Quality
System and overall strong product documentation records.
What You Will Be Doing
Essential Duties & Responsibilities
- Provide effective tactical Quality leadership for Quality
Engineers and direct reports.
- Supervise employee's and help them to establish the Quality goals
and requirements for programs.
- Interact and communicate with Senior Leadership across the
company regarding program status, risks, mitigation plans and
- Effectively deploy and assure compliance with our Quality System
such as design controls, risk analysis/management tools, design
validation, design verification, investigations, CA/PA data, etc.
to assure product quality.
- Support manufacturing site inspections/audits, representing and
defending product quality across design controls, risk
analysis/management tools, design validations, design
verifications, investigations, CA/PA data, etc Interact directly
with regulatory agencies during audits including Notified Bodies
- Assure site systems conform to all applicable company standards,
US, and international regulatory requirements and coordinate
development of data and responses to regulators.
- Understand Medical Device regulations and assure our Quality
Systems and documentation remain compliant
- Perform these and other duties as necessary or required, the
inclusion of which will not alter the basic scope of the
- Actively demonstrating support through interactions with solid
communication skills, attitude, dedication, commitment, respect,
pride and trust.
- Demonstrated leadership capabilities with strong inter-personal
- Ability to communicate at all levels of the organization
regarding project and business objective status, risks and
- Demonstrated knowledge of Quality Management Systems and
experience linking risk management to all elements of the Quality
System (Design Controls, CAPA, Complaints, Document Control,
- Systems level product development experience with an appreciation
for interactions of components, materials, drugs and manufacturing
What You Need for this Position
Education and Experience
- Bachelor's degree from an accredited institution in engineering,
engineering management or a related science field is required,
along with formal training in quality engineering.
- A MBA or Master is preferred, but not required.
- Six Sigma Black Belt, ASQ, CQE, and/or CQM certifications highly
- Minimum experience 5 years and 10 years preferred
What's In It for You
- Relocation Bonus
- Annual Bonus
So, if you are a Quality Engineer Manager with Consumables
experience, please apply today!
- Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, national origin,
disability, protected veteran status, or any other characteristic
protected by law.
Your Right to Work In compliance with federal law, all persons
hired will be required to verify identity and eligibility to work
in the United States and to complete the required employment
eligibility verification document form upon hire.
Keywords: CyberCoders, San Clemente , Quality Engineer Manager (Consumables), Executive , San Clemente, California
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