Quality Assurance Associate Engineer Jobs

• May work with management to update job training matrix.

• May track and report deviation QC trends to management.

• Coordinates and schedules all assigned quality control projects with minor assistance from coworkers and manager.

• Participates in continuing education through self-study, attending training sessions and lectures and meetings.

• Supports safety, quality, and 5S requirements and initiatives.

• Complies with company's procedures and regulatory requirements, as applicable.

Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below)

Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager

Transfer materials between facilities (see lifting requirements below)

Required experience in GMP and FDA regulated environments (ISO 13485:2016preferred)

1 year experience in regulated industry highly desirable

Perform line clearance activities and in-process inspections

Work with Department management to assign personnel and training materials to the appropriate Job Roles/curricula in Veeva

Interact with internal customers at various management levels to provide customer service

Manage GXP central filing system

Support Quality Control data entry processes

Minimum of 1-3 years of experience in a pharmaceutical and/or biotech company.

Advanced computer capabilities including all MS Office products

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

Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data

Support QA management to ensure product quality and compliance with cGMPs .

Familiar with ISO 9001, FDA QSR requirements

Exceptional written and verbal skills

Typically requires 2 years of related experience.

The estimated pay scale for the Quality Assurance Associate role based in Vista, CA is $23.52 - $35.28/hour depending on experience

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

Must possess organizational skills with the ability to use resource materials to manage multiple projects

Reviews customer purchase orders, specification and prints to ensure processing meets all requirements

Experience in diffusion coatings operations and processes/equipment typically used in a coatings-manufacturing environment

Proven ability to combine theoretical training with practical experience in a "hands-on" environment

Excellent written and verbal communication skills

Experience with ISO/AS quality systems

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.

Supports the maintenance and upkeep of the Quality Management System (QMS).

Manages the review cycle of QA controlled documents to assure practices reflect written procedures.

Knowledge of current GCP regulations preferred.

Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program.

Supports clinical sites and vendors/suppliers.

Supports internal audit program and performance metrics system for continual improvement.

Updates, maintains and improves quality management systems process documents and documentation

Supports during regulatory inspections, audits and Management Reviews

Tracks, reviews and assists in organizing reporting metrics and data for use in continuous improvement and Quality Management System reviews.

A minimum of 3 years of relevant work experience in a GMP environment.

Health Benefits: Medical, Dental, Vision

a minimum of 3 years of relevant work experience in a GMP environment.

• Participate in the development, implementation, optimization, and maintenance of the company’s Quality Management Systems

• Perform other quality or compliance related duties, as assigned by management

• Ability to develop and maintain effective working relationships at all levels of management

• Support the Equipment Program by reviewing executed qualification protocols or calibration certificates, as needed

• 3-5 years related experience in Quality Assurance, strong preference for direct QA support of manufacturing

• Knowledge and understanding of quality assurance in a manufacturing environment, laboratory controls and safety

·2+ years of Quality Control experience in a manufacturing environment (preferred)

· Knowledge of Sanitation GMP, HACCP, SSOP

· Demonstrates experience in the food processing environment, encouraging food safety culture with coworkers.

· Experience working under Health Department and FDA guidelines.

· Team building/team leadership skills.

· Computer skills, including Office, Excel, and PowerPoint.

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

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

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