Associate Quality Assurance Engineer Jobs

May participate and/or perform vendor audits and qualifications. Participate in supplier approval and management activities.

Supplier Management/Production & Process Controls

Preferred: ASQ Certification, Lead Auditor Certification, ISO 13485 and/or FDA-regulated experience.

Maintain product quality by enforcing quality assurance policies and procedures and government requirements; collaborating with suppliers and operations when appropriate.

Resolve non-conformities and manage related CAPA activities.

2-5 years relevent work experience in a regulated industry

Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.

Knowledge / Skills / Abilities

Experience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusions.

Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.

Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).

Investigate customer/sales force complaints and assure complaints are investigated accurately and closed in a reasonable amount of time.

Monitor field installation of vendor work to ensure compliance with contract documents and quality assurance requirements are met.

An independent thinker with excellent organizational and interpersonal skills.

Basic computer skills and user skills for web based business applicaitons

Excellent written, communication and presentation skills.

Exposure to industry codes, standards and regulations (ISO 9001, ASME IX, AWS D1.1, ASNT, ASTM). AWS and NDE certifications.

Fundamental knowledge of power system concepts

Excellent organizational and time management skills

Essential Knowledge, Skills and Abilities

Review and evaluate design and requirement documentation

Bachelor or Associate’s degree, or equivalent work experience in software development or related field.

Must have QA work experience outside of a school setting, preferably 1 to 3 years

Experience working under Agile (Scrum or Kanban) methodologies a plus

Responsibilities for corrective action by using a variety of analytical and statistical tools.

Review customer complaints and drive resolution.

Quality Develop, implement, monitor, and control QA system to assure quality based on customer and/or product specifications.

Interface with customers and suppliers to resolve quality problems.

Develop motivate, and train qualified personnel to QA standards.

Develop Control Plans, FMEA’S, Flow Charts, etc.

Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, quality system review.

Utilize knowledge to improve operational efficiency.

Exceptional written, oral communication, and organizational skills required

Effective verbal and written communication skills.

Excellent interpersonal, teamwork, and leadership skills required.

Oversee and review executed electronic and paper batch record documentation.

Perform any related work as required, based upon experience and training, such as:

Equipment calibration and qualification form maintenance and tracking

Minimum of 0-2 years of experience in a GMP/ISO setting

Excellent interpersonal, verbal and written communication skills are required

Attention to detail, organizational skills, ability to multitask and follow tasks through to completion

Revision and creation of documents, including SOP’s and forms

Collaborating with project management, developers, and designers to ensure the right level of quality exists in our features

Cross-browser and mobile device testing for web applications and mobile applications (experience with both is not necessary)

You have 3+ years of experience working as a QA tester

Automated testing is not a requirement but will be considered

Working across numerous early-stage products to manually test any functionality prior to being released to production

Being a part of a highly motivated team that is building beautiful, impactful products for U.S.-based clients

Reports to: Manager, QA Engineering

3+ years of software testing and test development experience

Proven experience building high quality and comprehensive test plans and test cases custom software

Proven experience testing web applications, web APIs and data driven applications

Proven experience with CI/CD pipelines

Experience in an Agile delivery environment

B.S. Degree or equivalent experience required; Microbiology/Biology/Chemistry/Engineering related degree preferred

Strong root cause analysis and technical writing skills required

Minimum 2+ years of experience in a Quality related role – preferably in the pharmaceutical or a healthcare related industry

Experience working in an FDA or USDA highly preferred

Excellent communication, organization, and leadership skills

Ensure regular presence and provide guidance in operational areas to monitor and ensure robust compliance and quality systems

Bachelors’ degree in a scientific discipline or the equivalent combination of education and experience.

Excellent writing and communication skills and experience with use of computers and software.

Knowledge and experience with MasterControl™ or similar software would be a plus.

Generate, publish, and manage quality systems metrics to drive continuous improvement.

Supports the commissioning and qualification of new equipment, instruments, including computer systems.

Maintains and enhances validation programs for existing equipment, utility commissioning and qualification, and computer systems.

Health Care Plan (Medical, Dental & Vision)

Life Insurance (Basic, Voluntary & AD&D)

Paid Time Off (Vacation, Sick & Public Holidays)

Short Term & Long Term Disability

Excellent organizational and project management skills; able to track and manage complex processes from start to finish

Management and/or mentorship of junior level staff as they are on-boarded into the department

This is a fully Remote and Work From Home (WFH) opportunity within the US

No current direct reports however line management could be a possibility.

Knowledge of cGxP regulations, CSV process and industry best practices

Analytical and problem-solving skills, with ability to operate at all organization levels

Perform routine and basic analysis, testing and certification of software

Review user requirements to ensure that requirements are testable

Fraud and Claims Operations experience

Experience with ACH and/or Debit Card claims processing

Experience taking initiative and work independently with minimal supervision

Experience with Agile and other software development methodologies and testing tools, such as Jira and ALM

B.S. in Engineering/Chemistry/Biology/Technical or Science Discipline or equivalent combination of certification and work experience

Reviews procedural deviations for compliance to internal quality and external regulatory requirements

Computer skills – proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.

Knowledge of quality systems and regulations for medical device industry

1-2 years of industry experience in medical device or equivalent s

Supports departmental activities in reducing product rejection, scrap and variances, and improving both the quality and business systems inefficiencies

Education: Bachelor’s degree required. Engineering or technical degree preferred. ASCP certification preferred.

Health Spending Accounts & Flexible Spending Accounts

Disability and Insurance: Short + Long Term

Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.

Join us—Where your Career is a Force for Good!

Work where your career is a force for good.

Minimum 3 years of related experience or equivalent combination of education and related experience required.

WHAT YOU NEED TO SUCCEED:

Health Spending Accounts & Flexible Spending Accounts

Disability and Insurance: Short + Long Term

Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.

Join us—Where your Career is a Force for Good!

Participate in Clinical Department QAPI meetings, Quality Management Department meetings, and staff meetings, as required.

NYC Health and Hospitals offers a competitive benefits package that includes:

Develop monitoring tools based on Federal, State, Joint Commission, H&H, and hospital requirements.

As necessary, provide feedback and education to appropriate providers either concurrently, during education and feedback sessions, or during meeting sessions.

Provides education and assists with interpretation of TJC standards and CMS conditions of participation.

Comprehensive Health Benefits for employees hired to work 20+ hrs. per week

Review, evaluate and investigate deviations. Work with Operational management to properly close variances. Coordinate corrective actions with Operational staff.

Assist QA Management or Specialists to train staff on Quality systems.

B.S. degree with a major in biological science, medical technology or related discipline; or equivalent combination of experience and education

0-2 years of cellular or biological manufacturing experience including quality assurance responsibilities

Author, review and qualify controlled documents such as standard operating procedures (SOPs) to achieve compliance with regulatory and accreditation requirements.

Experience with computer databases and competent with MS Office programs

Project management skills with ability to manage and collaborate with internal & external partners.

Proficient skills in Microsoft Office (Excel, Word, PowerPoint), Microsoft Outlook, MS Teams, OneNote and SharePoint. Experience with Minitab a plus.

Successful candidates must possess, as a minimum, the following competencies, skills and/or abilities:

Technical writing and root cause investigation skills.

Manage quality activities to ensure release of raw materials, intermediates, and finished products.

Manage product quality attribute metrics system.