Quality Engineer

Straumann • Andover, MA

4d • $108,450 - $132,550 • Onsite

About The Position

The Quality Engineer provides support to Quality and Manufacturing in areas of quality assurance. This role will actively participate in continuous improvement and technology transfer projects, to ensure compliance to product specifications and the quality system, while supporting production and QC operations and other duties as assigned by the Head of QARA.

Requirements

• Bachelor’s degree in engineering or related field
• Minimum 5 years of experience as an engineer in a related field
• Excellent knowledge of GMP and ISO standards

Nice To Haves

• Working knowledge of sampling, statistical analysis, failure investigation, troubleshooting, validation, process capability, DOE, GR&R, quality assurance, and quality systems in a medical device environment
• Must be meticulous, conscientious, customer service-oriented, a team player-learner with strong written and oral communication skills
• The ability to work independently in a dynamic manufacturing environment
• Analytical problem-solving skills
• Strong skills for planning, time management, organization and presentation.
• SAP/PLM experience a plus
• The ability to train employees at all levels

Responsibilities

• Support manufacturing by analyzing defect conditions as necessary to implement corrective actions and perform day-to-day troubleshooting and resolve immediate problems on the manufacturing floor
• Support continuous improvement activities
• Support customer complaint investigation in collaboration with Operations
• Support qualification / validation efforts as defined in Validation Master Plan; including qualifying equipment, validating processes, data analysis, risk assessment, and monitoring of ongoing inspection activities. Provide complete, accurate, and well-organized documentation for requirements, plans, reports, PFMEA’s, checklists, etc. in conjunction with the validation team
• Support on-going compliance through re-validation evaluation
• Perform product and process evaluations to identify areas for improvement. Recommend solutions to identified problems; Implement approved changes using sound quality engineering principles and fully document them in compliance with QSR and ISO standards
• Perform process capability studies, design experiments, risk analysis, gage repeatability and reproducibility studies, statistical evaluations as necessary to increase control and lower total quality costs
• Support technology transfer of processes / articles by providing complete, accurate, and efficient quality plans; this includes sampling points and plans, process control requirements, test methods, measurement technique and evaluation criteria throughout the manufacturing process
• Develop and write processes and generate ECO's as required
• Support document control and other departments as needed
• Participate in meeting departmental goals and objectives
• Lead cross functional projects as assigned
• Other duties as may be assigned

Benefits

• Competitive 401(k) Plan with 4% company match.
• Comprehensive medical, dental and vision insurance programs
• Short and long-term disability plan
• Competitive total compensation plans that might include a discretionary bonus based on department and level within Straumann.
• Paid time off policy

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level