Quality Engineer w/Medical Experience

Quality Engineer w/Medical Experience Personnel People

• 4.

0 Attleboro, MA Job Details Full-time Up to $95,000 a year 1 day ago Benefits Paid holidays Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Employee discount Life insurance Qualifications Mechanical engineering Databases Math Bachelor's degree Root cause analysis

Full Job Description Responsibilities:

Manage problem-solving activities to determine containment, root cause, and effective corrective action and other activities for internal and external customers Interface with customers and suppliers, as required, to resolve quality issues Perform and assist with internal investigations for customer complaints and/or deficiencies Manage cross functional team for investigations to resolution and disposition Review and disposition nonconforming material reports and First Article Inspections Maintain and improve the quality system to ensure compliance with ISO and regulatory standards Provide support during external customer, supplier, and regulatory body audits and factory inspections Participate in Internal Quality Auditing program Ability to interpret complex drawings, documents, and specifications to facilitate product / process implementation Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements Participate in Quality Planning activities in support of contract review, new product introduction, and Quality System improvements Create and update documentation such as Procedures (SOPs), Work instructions, and controlled forms Participate in the identification, planning, implementation, and monitoring of continuous improvement projects to reduce defects and improve overall product quality Manage and maintain quality data including design and validation of new or existing databases, queries, and reports Prepare, present, review, and analyze quality data to identify trends and draw effective conclusions Provide general oversight and training on Quality procedures, GMP, GDP, and other practices Work with cross-functional teams to facilitate the execution of

PFMEAs, Control Plans, and Process Flowcharts Qualifications:

Previous experience in quality engineering experience in the medical device and/or biotechnology fields, or equivalent Bachelor degree in engineering, the sciences or another technical discipline Previous knowledge within a medical device environment Experience in mechanical engineering and knowledge of a machine shop environment a plus Strong blueprint interpretation and Geometric Dimensioning & Tolerancing skills Excellent oral and written communication Advanced math skills and sound understanding of statistical analysis; previous experience with Statistical software (e.g., Minitab) is a plus Background in APQP, PPAP, and hands-on experience with Process Flow Charts, PFMEAs, and Control Plans Advanced computer knowledge and proficiency with Microsoft Office tools Basic knowledge of ISO9001 and

ISO13485. FDA

knowledge a plus Certified Quality Auditor and/or Certified Quality Engineer is a plus Hours Monday through Friday

• 8am to 4:30pm This is a salaried position $75 to $95K based on experience

Benefits:

Health insurance

• Blue Cross Blue Shield Dental insurance
• Delta Dental Vision insurance
• Superior Vision 401K with matching Voluntary term life insurance Voluntary accidental insurance Employee discount Paid time off 10 Holidays Vacation time is accrued
• 80 hours for first 5 years, 120 hours for 6 to 14 and 160 hours for 15+ years 40 hour sick time

Pay:

Up to $95,000.00 per year

Work Location:

In person