We need Quality Engineers / Manufacturing Engineer people with medical device experience Job in Telecommute

We need several medical device people all over the USA, some with base salaries up to 150k

You must have medical device industry experience in the USA or Canada, no exceptions

We have several pharma, healthcare jobs all over the USA 

Some of these positions can be found at http://www.anewbeginning-genesis2.com

Regards, ciao, Namaste, Peace
Joe
Joseph Anthony Vaccariello
joseph8601@sbcglobal.net
A New Beginning-Genesis 2
860 889 4141, until 9 PM Eastern, 7 days a week

We need quality engineer / manufacturing emgineer medical device people for position 1 hour north of Albany NY.

We are flexible on the skiils

We do not expect any one person to have all the experience below

Quality Engineer / Sr. Manufacturing Engineer, either or
Responsible for assuring product quality through participation in cross-functional product development teams and by supporting manufacturing operations.
Position Responsibility and Authority:
• Provide QE support for existing products and assist with the transfer of new products to production to drive continual improvement.
• Utilize quality tools to implement quality improvements, process mapping, process validations, software validations, production efficiency improvements, and process controls.
• Support product complaint failure investigations.
• Create and/or approve process validation protocols and reports.
• Initial corrective action reports as appropriate and investigates and implements corrective and preventive action plans.
• Participate with the material review board in determining the disposition of nonconforming materials.
• Design verification and validation strategy development and review and approval of validation and verification protocols and testing activities.
• Assist with the development of internal quality control inspections and implementation of appropriate measurement methods and test equipment.
• Develop and maintain supplier performance program.
• Provide statistical analysis support where appropriate (e.g. SPC, design of experiments, etc).
• The above is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.
Required Skills
• Requires in-depth knowledge of FDA cGMP/QSR’s and ISO 13485 standards.
• Proven ability to use MS Word, Excel, and databases.
• Statistical Process Control and knowledge of statistical analysis techniques.
• Validation/Qualification/Verification protocol development.
• Excellent organizational skills.
• Good verbal and written communication skills required.
• Software validation/verification and supervisor experience preferred.
• Certified Quality Engineer (CQE) is desirable.
Required Experience
responsible for continuous process and product improvement within the production facility. This role would perform problem solving, technical analysis, process validations, and other related engineering functions to further operational goals. The Sr. Manufacturing Engineer also acts as an interface between RD, Process Engineering, and production for applicable engineering projects.
Position Responsibility:
• Support a CFM environment through the development, validation, implementation and documentation of manufacturing process improvements.
• Actively participate on project teams to support the introduction of new products in a professional and cooperative interdepartmental atmosphere.
• Provide support to the production group by:
o resolving process related issues as they arise
o assisting in training of production personnel
o monitoring production lines for potential process improvements while suggesting/implementing changes as necessary
• Provide technical support to others within the organization on an as-needed basis
• Negotiate and establish contracts with outside suppliers for equipment and machine design and fabrication.
• Lead efforts to investigate and perform root-cause analysis of manufacturing process issues. These investigations may stem from in-line failures, NCMR’s, customer complaints, audit findings, CAPA’s, and more.
• Utilize relevant statistical data and other analytical tools to implement sound corrective actions to permanently resolve production concerns.
• Ensure the effectiveness of process improvements by developing and monitoring relevant metrics.
• Monitor production metrics related to in-line scrap and labor efficiency to identify areas for improvement. Lead improvement projects as assigned.
• Identify and lead operational excellence projects with focused elements such as: Lean, quality enhancement, and Six Sigma.
The above is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.
Required Skills
• CGMP and medical device industry experience preferred.
• Successful track record utilizing Six Sigma and Lean Manufacturing methods to identify opportunities and implement improvements in manufacturing processes.
• Successful experience in the application of statistical analysis towards problem solving and process optimization.
• Strong knowledge and experience with root cause analysis and corrective action.
• Demonstrated proficiency in all facets of communication.
• Flexible for directional changes and re-prioritization.
• Ability to drive quality results with limited oversight.
Required Experience
• Bachelors degree in Engineering or related field.
• Six Sigma training preferred.

Regards, ciao, Namaste, Peace
Joe
Joseph Anthony Vaccariello
joseph8601@sbcglobal.net
A New Beginning-Genesis 2
http://www.anewbeginning-genesis2.com
860 889 4141, until 9 PM Eastern, 7 days a week