Senior Quality Engineer
Amerit Consulting Glencoe, MD
- Expired: over a month ago. Applications are no longer accepted.
Position: Senior Quality Engineer
Location: Sparks MD 21552
Duration: 12 Months Contract
Pay Rate: $45/hr - $52/hr (depending on experience)
Relocation Expenses/ Assistance: NO
- Workdays/hours: M - F 8am - 5pm
- Locals only (or should be able to relocate on their own), must be able to go to the office at least 2X/week.
- Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services.
- The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured. Demonstrates intermediate knowledge of quality engineering policies, principles and best practices.
- Demonstrates intermediate knowledge of FDA/ISO requirements.
- Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity.
- May act as mentor to less experienced team members. Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision. Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended.
- BS in related field required with minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or 5 years in manufacturing environment or MS with 3 years of experience.
- Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or another related field.
- Experience and understanding of electro-mechanical instrumented systems. Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma preferred.
- Has in-depth experience, knowledge and skills in own job family.
- Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance
- Usually determines own work priorities
- Acts as a resource for colleagues with less experience
- Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2015 and ISO 13485:2016
- Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity
- Ability and skill to effectively manage multiple tasks and drive execution of change management plans
- Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC Six sigma, additionally root cause analysis and project management techniques are routinely employed
- Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
- Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
- Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
- Experience with complaint investigation
- Professional certification preferred. Six Sigma, ASQ, AAMI
- Experienced in Microsoft Office suite skills. Basic mini tab and/or related analytical software programs
- Preferred: Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.
Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.
Amerit ConsultingWhy Work Here?
We create value by bringing together the right people to achieve results.
Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward. Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.
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