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Development Quality Engineer Ii Jobs

Quality Engineer Ii Jobs
By Viant Medical At Wheeling, IL, United States
Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
Lead and manage complaint investigations.
Coordinate and lead preparation of Quality Plans including inspection, test and gauge requirements for new product introductions.
3+ years’ experience in medical device or other regulated manufacturing industry Bachelor’s Degree in related field.
Strong communication skills and ability to align with key stakeholders.
Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Engineer Ii, Quality Validation
By Integra LifeSciences At , South Boston, 02127, Ma $77,368 - $93,174 a year
Practical knowledge of project management
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Contribute to risk management activities including PFMEA generation.
Experience of utility qualification, equipment qualification, process validation, packaging validation, distribution studies, aging studies.
Specialized knowledge level, seasoned professional with complete and in-depth conceptual and practical knowledge in one or many areas of Quality Validation
Applies knowledge of job discipline's best practices to internal processes
Quality Engineer Ii, Quality Management Systems
By Donaldson At , Bloomington, Mn
Supports development, implementation and management of quality training and education programs
Oversees the design and implementation of a global Quality Management System
Establishes a common set of quality analytics to proactively monitor quality management systems including audits, documentation control, training
Oversees and manages compliance auditing and tracking, including the shared audit management process
Knowledgeable in current regulatory and/or quality certification(s) such as CQA, CBA, CQM, RAC, etc.
Demonstrated knowledge in quality processes and regulatory requirements such as ISO 9001, ISO 13485
Software Quality Engineer Ii
By Rite Aid At ,
Strong knowledge of test and defect management tools like Jira/Azure DevOps required.
EXPERIENCE, SKILL and ABILITY REQUIREMENTS:
Strong knowledge and experience with testing methodologies required.
Capture and generate software quality metrics and status reports for assigned team to management
Utilize defect management tool to log and track all defects identified during testing
EDUCATIONAL, CERTIFICATE and LICENSE REQUIREMENTS:
Quality Associate Ii Jobs
By Takeda Pharmaceutical At , Round Lake Beach, Il
Leads cross-functional teams in the execution of risk management activities.
2+ years of related experience (regulatory/audit experience).
External Auditor Certification (e.g. ASQ Certified) desired.
Experience in the application of cGMPs.
Able to demonstrate excellent problem solving and critical thinking skills and understanding of complex manufacturing processes.
Experience in utilization of electronic systems such as TrackWise.
Quality Engineer Ii Jobs
By Zimmer Biomet At , Jacksonville, Fl
B.S. in engineering or an alternative bachelor’s degree program with certification as a quality engineer (e.g. CQE).
Minimum 1 year of relevant work experience.
Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred
Formulates procedures, specifications, and standards for Zimmer products and processes.
Develops and implements corrective/preventative action plans.
Collects and analyzes data for gauge and product evaluation.
Quality Associate Ii Jobs
By Exact Sciences Corporation At , Madison, 53719, Wi $56,000 - $89,000 a year
2+ years of experience with electronic document management system software implementation.
Assists with administration and ensuring compliance to Quality Management Systems including auditing, document control, training, etc.
Creates, assigns and updates training in our Electronic Quality Management System.
Supports and complies with the company’s Quality Management System policies and procedures.
2+ years of advanced knowledge and practical skills in utilizing MS Word, Excel and Visio.
Possesses excellent oral and written communication skills.
Quality Analyst Ii Jobs
By TE Connectivity At , Plymouth, 55442, Mn $62,200 - $93,200 a year
Communicate significant issues or developments identified during quality assurance audits and recommend process improvements to the Quality Management.
Other duties as assigned by manager.
3 years experience in a regulated environment, preferably medical devices or comparable regulatory controls
Excellent verbal and written skills with technical terms in a design and manufacturing environment
Previous work experience investigating non-conformances, determining root cause and applying suitable corrective actions
Previous work experience in a cross-functional, team environment collaborating with different roles in a manufacturing environment
Quality Engineer Ii Jobs
By Enersys At , Warrensburg, 64093, Mo
Bachelor’s degree, Engineering, Quality Management, or related field and/or equivalent combination of education and experience
Ensuring correct nonconform and suspected product management
Minimum 3 year of relevant experience in a manufacturing environment
Knowledge of quality tools and methodologies (8D, 5WHY, Statistical Tools, SPC, etc.)
Excellent PC skills with the ability to produce high quality document deliverables in short time scales
SAP knowledge, desirably with quality module
Quality Engineer Ii Jobs
By Johnson & Johnson At , New Providence, Nj
Must have 2 years of experience in Quality Engineering
Strong communication, collaboration, and problem-solving skills are required.
Both, FDA, and ISO regulations knowledge is required.
Strong root cause analysis skills are required.
Operations supplier quality experience is preferred.
Experience in the medical device and/or pharmaceutical industry is preferred.
Quality Analyst Ii Jobs
By Advarra At United States
Maintain a working knowledge of SOPs, Federal Regulations, Guidance Documents and accreditation standards for human research subjects’ protection
Bachelor’s degree or equivalent work experience
Excellent organizational skills, managing conflicting demands and priorities, without compromising quality
Excellent written and verbal communication skills
Working knowledge of Federal regulations for human research (21 CFR 50, 56, 312, and 812; and 45 CFR 46)
Knowledge of inspection and quality control methods, techniques, and documentation
Engineer Ii, Software Quality Engineering
By Samsung Electronics At , Bellevue, 98004, Wa $150,075 - $170,075 a year

Reasonable Accommodations for Qualified Individuals with Disabilities During the Application Process

Compensation for this role between $150,075 – $170,075/Year

Quality Engineer Ii Jobs
By Medtronic At , Plainfield, 46168, In
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
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.
A Day in the Life
Sw Quality Engineer Ii
By NCR At , Atlanta, Ga

Offers of employment are conditional upon passage of screening criteria applicable to the job.

Full time employee benefits include:

Quality Engineer Ii Jobs
By BD At , San Jose, Ca
Degree level qualification; or equivalent combination of education and experience.
Notifies management upon recognition of factors that may affect project.
Ideal candidate will have 2-4 years’ experience in medical device industry.
Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485) helpful
Results oriented with strong written and oral communications skills to participate in cross-functional teams.
Strong problem identification and problem-solving abilities.
Air Quality Engineer I/Ii
By Bay Area Air Quality Management District At , , Ca
(1) full-time, represented position, in the Meteorology & Measurement
Examples of Duties for this Position
Conducts on-site compliance inspections of sources and abatement devices; evaluates compliance and recommends enforcement actions.
Conducts environmental audits, compliance inspections and source tests; evaluates results and recommends appropriate actions, including violation notices.
Operates, maintains and calibrates instruments; prepares and dismantles testing equipment and materials; fabricates specialized equipment.
Participates in calculating, reviewing and correcting the emissions inventory; evaluates accuracy of source emission calculations and methodologies.
Engineer Ii, Quality Jobs
By Boston Scientific Corporation At , Dorado, 00646, Pr
Bachelor degree in Engineering with at least 3 years of experience or an equivalent combination of education and work experience
Knowledge of Quality System Mfg Process
General Knowledge of industry practices, techniques, and standards
Knowledge of Quality and Traceability Systems (MESS/SAP/eCAPA/Windchill)
General knowledge of quality metrics
Responsible for the final Process Monitor Release for products prior to distribution.
Sr. Engineer Ii, Packaging Development
By Moderna At Norwood, MA, United States
Experience working in matrix teams preferable. Excellent written and oral communication skills.
Deep knowledge and understanding of material manufacturing and converting, product/packaging interaction, barrier properties, stability, global pharmaceutical packaging regulations, and package testing.
Knowledge of manufacturing and quality attributes for packaging components.
Strong interpersonal skills to support building productive relationships with suppliers and colleagues.
Strong priority setting skills and track record of developing and implementing new packaging designs.
Family care benefits, including subsidized back-up care options and on-demand tutoring
Quality Analyst Ii Jobs
By Maritz Inc. At , Remote
Analyzes and develops testing scripts or works with scripting team to provide requirements.
Create test plans, cases, and/or scripts that line up with functional requirements for proprietary systems/applications that supports company business objectives.
Provides good written requirements and oral communications when entering change requests and tasks to ensure proper understanding of business technical needs.
Performs other duties, responsibilities, and projects as assigned.
Reports to the Manager, Sr Manager, Director or Senior Director, IT. Works closely with technology teams
Responsible for creating test plans, testing, analysis and implementation of web-based applications.
Quality Engineer Ii Jobs
By Edwards Lifesciences At Draper, UT, United States
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Develop, update, and maintain technical content of risk management files
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Bachelor's Degree in an Engineering or Scientific field with 2 years of previous related work experience Required or
Experience with equipment, process, and tooling fixture validations
Experience with test method validations

Are you a Quality Engineer looking for a new challenge? We are looking for a motivated and experienced Quality Engineer to join our team and help us develop and maintain high-quality products. As a Quality Engineer, you will be responsible for ensuring that our products meet customer requirements and industry standards. You will also be responsible for developing and executing test plans, analyzing test results, and providing feedback to the development team. If you are looking for an exciting opportunity to make a difference and help us create the best products possible, then this is the job for you!

Overview Development Quality Engineer II is responsible for ensuring the quality of products and services produced by the organization. They are responsible for developing and implementing quality assurance processes, conducting tests, and analyzing results. They also work with other departments to ensure that products meet customer requirements and industry standards. Detailed Job Description Development Quality Engineer II is responsible for developing and implementing quality assurance processes and procedures. They are responsible for conducting tests, analyzing results, and making recommendations for improvement. They also work with other departments to ensure that products meet customer requirements and industry standards. They are responsible for developing and maintaining quality control systems, and for ensuring that products and services meet customer requirements. They are also responsible for identifying and resolving quality issues. Job Skills Required
• Knowledge of quality assurance processes and procedures
• Knowledge of industry standards and regulations
• Ability to analyze data and make recommendations
• Ability to work with other departments to ensure customer requirements are met
• Ability to identify and resolve quality issues
• Excellent communication and interpersonal skills
• Attention to detail and accuracy
• Problem-solving and critical thinking skills
Job Qualifications
• Bachelor’s degree in Quality Assurance, Engineering, or related field
• Minimum of 3 years of experience in a Quality Assurance role
• Knowledge of quality assurance processes and procedures
• Knowledge of industry standards and regulations
• Ability to analyze data and make recommendations
• Ability to work with other departments to ensure customer requirements are met
• Ability to identify and resolve quality issues
• Excellent communication and interpersonal skills
• Attention to detail and accuracy
• Problem-solving and critical thinking skills
Job Knowledge
• Knowledge of quality assurance processes and procedures
• Knowledge of industry standards and regulations
• Knowledge of product development processes
• Knowledge of statistical analysis
• Knowledge of quality control systems
• Knowledge of product testing methods
Job Experience
• Minimum of 3 years of experience in a Quality Assurance role
• Experience in developing and implementing quality assurance processes and procedures
• Experience in conducting tests, analyzing results, and making recommendations for improvement
• Experience in working with other departments to ensure customer requirements are met
• Experience in identifying and resolving quality issues
Job Responsibilities
• Develop and implement quality assurance processes and procedures
• Conduct tests, analyze results, and make recommendations for improvement
• Work with other departments to ensure customer requirements are met
• Develop and