Quality Engineer II - Exempt

Must Have:
1. Investigation and root cause analysis skills, 2. Technical writing knowledge, 3. Organization and Communication skills, 4. Process Validation and Computer software validation knowledge

JOB DESCRIPTION
What are the top 3 things you are looking for in a candidates experience:
Validation (IQ, OQ, PQ)
Corrective Action / Preventive Action (CAPA)
Support of manufacturing process
Education Required: Bachelors Degree in Engineering or technical field
Years Experience Required: 2-5 (if a good candidate with less experience is identified I dont have an issue changing the role to a Quality Engineer I)
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours
Work Location: North Haven, CT
Do they need to be local to any MDT office and if so where? Yes, North Haven site (60 Middletown Ave, North Haven, CT 06473)
Does this person need to be on site? If so, full time or part time? On site full time
Responsibilities may include the following and other duties may be assigned.
On site support of daily manufacturing operations including troubleshooting of equipment, investigation of defects, and validation of equipment/processes.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Must Have: Minimum Requirements
Bachelors degree required
0 years of experience required
Nice to Have
Experience working in a fast paced Manufacturing environment
Validation Experience (IQ, OQ, TMV, PQ)
CAPA (Corrective Action / Preventive Action) Experience
Familiarity with Minitab Statistical Software
Six Sigma Training

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.