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Quality Engineer Manager (Consumables)

Company: CyberCoders
Location: San Clemente
Posted on: May 31, 2019

Job Description:

Quality Engineer Manager (Consumables)
If you are a Quality Engineer Manager with experience, please read on!

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 business objectives.
- 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 and FDA.
- 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 position
- Actively demonstrating support through interactions with solid communication skills, attitude, dedication, commitment, respect, pride and trust.
- Demonstrated leadership capabilities with strong inter-personal communication capabilities
- Ability to communicate at all levels of the organization regarding project and business objective status, risks and recommendations/mitigations
- Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc)
- Systems level product development experience with an appreciation for interactions of components, materials, drugs and manufacturing processes
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 desirable.
- Minimum experience 5 years and 10 years preferred
What's In It for You
- Relocation Bonus
- Vacation/PTO
- Medical
- Annual Bonus
- Dental
- Vision
- 401k

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

Click here to apply!

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