Senior Quality Assurance Associate Jobs in Texas

Communicates confidently and effectively with management, peers, and key stakeholders.

Creates and reviews risk management documentation to reduce or eliminate risk.

Minimum 5 years In Quality or related field experience; Less experience may be appropriate with advanced degree.

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Experience with us of ethylene oxide and at least one additional sterilization modality (e.g. radiation, moist heat, dry heat)

Good interpersonal and organizational skills.

Experience with GMP audits, internal and relevant external audits

Experience with overseeing biocompatibility studies

Work directly with the BWI R&D teams to validated and transfer break-through technologies to enable future growth and innovations.

Drive selection of sterilization modality, validation approaches and validation of the sterilization process for new products, and the sites for execution.

Operate the ECO system within our electronic Quality Management System (eQMS)

Experience operating a change control system in a regulated environment (medical device, pharma, diagnostics) with five years of experience preferred

Strong verbal and written communication skills and interpersonal skills

Document Control including releasing approved documents and controlling revisions

Assisting other professionals with ECO creation

Routing ECOs and associated documents to the appropriate reviewers/approvers

Relevant certifications and/or experience may be substituted in lieu of this requirement

Assist the site QAS in collaborations, including problem-solving and continuous improvement efforts, and communications with the Facility Manager and Operations team.

Assist in the oversight of the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).

Support the site QAS and Facility Manager in aseptic operations compliance (e.g., cleaning, sanitation, organization, etc.)

Support compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.

Assists QAS, Directors, QA and Regional Managers, QA, etc. as necessary.

Three (3) years of professional experience within Technology or a related field

Two (2) years of professional experience in mobile applications quality assurance

Experience with XCode for iOS and/or Android Studio for Android

Experience with Charles Proxy or equivalent tool

Five (5) + years of professional experience within Technology or a related field

Knowledge of mobile app deploying to test app stores

Knowledge and experience with implementation, maintenance, and audit of Quality Management Systems (ISO 9001 or similar)

Excellent project management and organization skills

People: Accomplishes objectives through high quality recruiting, selecting, orienting, training, assigning, scheduling, and performance management of employees.

Quality risk identification and management

5+ years experience in manufacturing in chemical industry (surfactants and person care product manufacturing preferred)

5+ years of supervisory experience

Identifies and communicates substandard product performance or inadequate implementation of product requirements to engineering and management

Identifies, reproduces, and escalates new or persistent software or hardware related failure modes to management and appropriate Engineering teams

Represents department cross-functionally in meetings that may include engineers, management, and external personnel

Escalates to direct management all quality issues that could impact patient safety or surgical efficacy

Ensures successful, on-time completion of department projects; communicates constraints to direct management when successful project completion is at risk

Performs a broad variety of tasks in support of product and process design as assigned by department management

Prior experience with document management and record-keeping.

Administer Electronic Document Management Systems with a focus on Quality.

Bachelor's degree or equivalent experience in a relevant field.

Strong organizational abilities and attention to detail.

Excellent written and verbal communication abilities.

Ideal candidates would be needing the following qualifications:

Strong project management skills including the ability to handle multiple projects concurrently

Ensure customer issues are addressed while maintaining compliance with internal company requirements and standards and agency or government regulations

Mentor less experienced colleagues and assist with their development

Provide guidance to team regarding documentation and resolution requirements

Strong analytical skills with high attention to detail and accuracy

Excellent verbal, written, and interpersonal communication skills

Minimum of 5 years in quality management and supervision or related education, training, management and supervisory experience.

Assist with a training program to continually reinforce and upgrade personnel qualifications related to Quality Management Program.

Know and understand Floworks Quality Management System requirements, Operating and Technical Procedures and workplace instructions.

Working knowledge of personal computers as related to management software uses.

Perform various other duties as required by management, within the physical constraints of the job.

Understand and comply with all Safety and Environmental requirements.

Assist in the advancement, implementation or enhancement of quality processes and procedures, such as change control, CAPA, and risk management.

Assist in leading the Management Review meetings.

Support cross-functional teams to support all aspects of quality management, including documentation, testing, audit, and continuous improvement.

Coordinate complaint management activities and Customer Feedback activities.

Strong knowledge and/or experience with ISO9001:2015 or higher ISO

Conduct internal audits and assess compliance with ISO9001 standard and customer requirements.