Quality Engineer II

We are looking for a Quality Engineer II for a very important client.

As a Quality Engineer II at our Nathan Lane Manufacturing site, you will be at the forefront of driving excellence in our products and processes You'll leverage your experience to ensure our life-changing therapies meet the highest standards of quality, compliance, and reliability This role requires you to be onsite Monday through Friday, providing you the opportunity to collaborate closely with cross-functional teams in a fast-paced, hands-on environment.
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.

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.

3 main responsibilities/day to day activities required for this role: NCMRs and CAPA executions, Front Line support, A3 initiation as part of problem solving

Requirement:

The ideal candidate will possess the following requirements:

Must Have: Minimum Requirements -
Include: To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
• Bachelor's degree required in a related engineering discipline (mechanical, biomedical, manufacturing, etc.)
• Minimum 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.
• Bachelor's degree with a minimum of 2 years of relevant experience, OR an advanced degree with a minimum of 0 years of experience
Nice to Have -
• Experience reviewing technical documentation
• Previous process validation experience (including installation qualifications, process characterization, operational and performance qualifications)
• Previous experience with developing, executing, and analysis of Test Method Validations
• Previous experience with Master Validation Records and Risk Management documentation (including DFMEA and PFMEA)
• Strong written and verbal communication skills
• Strong critical thinking and analytical skills
• CAPA NCMR knowledge

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.

Top 3 skills sets required: Problem Solving, good technical writing and good attitude

Benefits:

Benefits
Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.

Compensation
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.

Work Authorization
ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.

ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.