Design Quality Engineer

Design Quality Engineer5+ years of experience & demonstrated proficiency in Design Quality & providing ongoing technical support is preferred with evidence of continued self-development.

Work experience in the Medical Device industry.

GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs

Strong creative, analytical and problem-solving skills.

Proficient at interpreting data and putting that data into a report

Proficient at statistical analysis

Experience in EU MDR or other regulatory related projects

Verification and Validation

CAD Support (Preferred Auto CAD and Solidworks)

Experience in creating PFMEAs & Writing reports? Process experience, ability to observe and understand manufacturing processes

Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred

Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software

Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:

Can Lead and Manage Team at onsite/offshore

Must Discuss with client for project plan and its implementation

Ability to understand the EUMDR project scope of impacted products and identify the affected parts and documents

Build the ECO strategy and work with affected cross functional teams

Update the affected CAD drawing files and product documents

Identify the potential risks/issues and accordingly plan for any changes required? Prepare Characterization Reports.

Prepare PFMEA? Develop and establish effective quality control and associated risk management plans? Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)

Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans

Work in a cross-functional team environment, working with engineering, manufacturing, marketing and suppliers

Creation of ECOs to upload documentation changes to PLM system

Know & follow policies & procedures related to work activities performedin area of responsibility

Complete training in area of responsibility within allowed time-period and periodic retraining in areas

Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.

Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.

Employee must be able to effectively prioritize and manage multiple activities and responsibilities.

Ability to understand and follow complex written procedures is required.

Ability to lead and manage team at onsite and/or offshore

Ability to function in a team environment and deliver on team objectives is required.

Ability to make decisions and solve problems while exhibiting situational judgement.

A Minimum Bachelors Degree in Engineering, Science or related technical field

How many years of experience does the candidate have in Medical Device Domain or Industry experience

(Minimum requirement is 5 years, more than 5 is ideal).

Does the candidate have knowledge in Design Quality Engineering Domain and Project Management