Position SummaryThe 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.
Job Responsibilities This position is responsible for, but not limited to, the following:
- 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
Minimum Qualifications:- 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
Preferred Qualifications:- 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
Physical Attributes: - 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 work station
- May lift up to 25 lbs at any given time
- Will be working in a fast-paced, team environment
Work 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 and $132,550/Annually. The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position.
Whether you're looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.
- Competitive 401(k) Plan with 4% company match. Comprehensive medical, dental and vision insurance programs and short and long-term disability plan to meet your financial and healthy well-being needs.
- Competitive total compensation plans that might include a discretionary bonus based on department and level within Straumann.
- Paid time off policy
Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.
Videos To Watch https://youtu.be/3lq5BLAvIdQ
Employment Type: Full Time
Alternative Locations: United States : Andover (MA)
Travel Percentage: 0%
Requisition ID: 20951
