Quality Engineer

Position Title:

Quality Engineer

Location:

Andover (MA), United States

Company: BMUS - Bay Materials LLC

Job Category:
Quality Assurance

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, QC operations and other duties as assigned by the Head of QARA.

• 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 ongoing 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.

• 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.

• 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.

• Observe and hear warning signs and signals within all areas of the company.
• May stand or sit for up to 8 hours at a time at a given workstation.
• May lift up to 25 lbs at any given time.
• Will be working in a fast‑paced, team environment.

• Work is performed in a manufacturing environment.
• The employee may occasionally be exposed to dust.
• The noise level in the work environment is usually low to moderate.
• Will work in a fast‑paced, team environment.

• Salary: $108,450 – $132,550 annually. Final pay varies based on geographic location and candidate experience.
• 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.

• Employment Type:
  
  Full Time
• Alternative Locations:
  United States – Andover (MA)
• Travel Percentage: 0%
• Requisition

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Straumann Group is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national origin, age, veteran status, or disability unrelated to job requirements.