Senior Quality Engineer
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Job Title: Senior Quality Engineer
Location: Beverly, MA
Duration: Direct Hire
POST-OFFER BACKGROUND CHECK IS REQUIRED. An essential function of this job is physical attendance. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Maintain the quality system and support outgoing product quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices.
ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.
- Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
- Make effective use of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE to solve quality problems and mitigate product and process risks.
- Make use of Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D and other problem solving techniques.
- Approve Engineering Change Orders, review prints and be familiar with Geometric Tolerancing.
- Maintain Quality Records.
- Perform Corrective Actions and Non-conformance assessments.
- Assist in investigating customer complaints.
- Perform internal audits as well as supplier audits.
- Support Incoming Inspection.
- Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends.
- Participate in and lead continual improvement projects
- Support environmental and sterilization monitoring
- Travel for supplier and R&D support
- Mentor other members of the quality assurance team in statistical and problem solving techniques.
- Execute cross functional projects using project management methodologies such as critical path methodology, critical chain.
- Identify and prioritize continual improvement ideas.
In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.
- Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent experience; advanced degree is preferred
- Very good written and verbal communication skills.
- At least 8 years of quality engineering experience.
- Good written and verbal communication skills.
- Experience working in a production environment
- Proficiency with Microsoft Office tools.
- Proficiency with basic statistics (mean, standard deviation, etc.).
- Experience working in medical device or another regulated industry.
- Experience with mechanical inspection techniques and/or metrology.
- Experience as an internal, external, or supplier quality auditor.
- Ability to apply statistical tools to quality problems.
- Proficiency with Minitab statistical software.
- Experience with root cause analysis and corrective and preventive action.
- Proficiency at reading engineering drawings and schematics.
- Risk management experience.
- Gage R&R study development.
- Experience managing measurement equipment calibration.
- Project management experience.
- Experience with biocompatibility and sterilization testing.
- Desirable additional qualifications:
- Familiarity with ISO 13485, EU MDR, and 21 CFR Part 820.
- Lean Six Sigma experience.
- ASQ Certified Quality Engineer
- Knowledge of Geometric Dimensioning and Tolerancing.
Experience developing process metrics.
Make this your next career move as one of our many long-term contractors or employees!
Work as our full-time employee with full benefits (Medical, Dental, Vision, STD, LTD, PTO, Retirement, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
ABOUT DIGITAL PROSPECTORS:
Founded in 1999, Digital Prospectors is an award-winning recruiting and consulting firm that specializes in placing contract, contract-to-hire and direct hire engineers into rewarding opportunities with our impressive and ever-growing client base. We believe that all people should love their jobs.
Come see why Digital Prospectors has been voted “Best Staffing Firm to Temp For” by Staffing Industry Analysts, "Best of Staffing" for candidate satisfaction by Inavero / CareerBuilder.com, "Top Temporary Placement Firm" by Boston Business Journal, "Best Company To Work For" by Business NH magazine, "Excellence in IT and Engineering Staffing” by TechServe Alliance, "Top IT Services Company" by Inc. Magazine, "Most Reliable Staffing Agency" in Forbes Magazine and "Top Ranked Staffing Firm" by Staffing Industry Analysts.