Easter Seals Jobs

The Quality Assurance Engineer is responsible for ensuring compliance with all applicable regulatory requirements, quality and industry standard as well as company quality policies in the manufacturing of medical devices, drug products and cosmetics. The role involves developing, implementing and auditing quality control systems as well as driving continuous improvement initiatives and proving quality/compliance related training to ensure that the highest standards of product safety, efficacy and quality are maintained.

Responsibilities:

Develop, implement, and maintain quality assurance programs and procedures in accordance with FDA (21 CFR 820, 21 CFR 210/211, MoCRA), ISO 13485, and other applicable regulatory requirements.

Provide cGMP, GDP and Quality Systems training; regulatory requirements training and continuous improvement methodologies training and guidance to employees by:

• developing training materials and delivering quality related training.

• Training trainers, identifying and addressing quality related training gaps as well as coordinating training Programs/activities as needed.

Conduct, manage and participate in the Internal and External Audit programs by:

• conducting internal audits, writing audit reports, following up on associated non-conformances to ensure resolution and effective closure.

• Participating in external (regulatory and customer) audits as well as supplier audits and leading CAPA investigations to ensure adherence to quality standards.

• Drafting audit responses and guiding investigations/Root cause analyses/CAPA to non-conformances raised.

• Carrying out effectiveness verifications to audit findings.

• Training departments and SMEs on audit readiness.

Participate in the development and maintenance of the QMS and related procedures and policies by:

• Developing and/or reviewing SOPs, Work Instructions and other on Quality systems documentation such as Specifications, Test Methods, PFMEAs, Templates and Forms to ensure that documentation meets customer, compliance and business requirements.

• Independently gathering information from subject matter experts to develop, organize, and write procedure manuals, technical specifications, and process documentation.

• Assuring cGMP, ISO, FDA and Quality System compliance by revising quality documents such as: Quality Manual, Quality Systems Procedures and Quality Specifications as required by internal standard operating procedures.

• Reviewing Quality Agreements and ensuring that customer requirements are considered in Quality documentation.

• Monitoring existing processes through trending and identifying and implements process improvements.

• Leading root cause analysis investigations and driving corrective actions for non-conformances, complaints, OOS and deviations.

• Analyzing manufacturing processes and identifying areas for quality improvements, efficiency enhancements, and defect reduction.

Customer complaint Handling:

• Participating in the development of maintenance systems used to manage complaints.

• Investigating complaints, working collaboratively with impacted departments to implement CAPA, drafting responses to customers and managing the customer interface for the same.

Ensure the timely and effective processing of key Quality drivers such as CAPAs; NCRs; OOS; APRs, Stability Program, CMRs and Deviations and their progress against established thresholds by:

• Tracking and reporting progress to management.

• Identifying resources/resource gaps and bringing them to management attention.

• Reviewing and/ or approving CAPAs, Deviations, NCRs, Validations, CMRs, OOS, APRs, Complaints and related protocols.

• Tracking, trending and reporting key KPIs and metrics for management review.

Supporting design control activities, risk management, and process validation efforts to ensure compliance with regulatory and industry standards.

Additional Skills & Qualifications

• Bachelor’s degree in Life Sciences, Engineering or related technical field.

• 6-8 years work related experience in Quality Compliance, Quality Control or quality systems within medical device, pharmaceutical or similar regulated industry.

• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, cGMP, and related industry standards.

• Experience with process validation, equipment qualification, and statistical analysis tools.

• Proficiency in quality tools such as FMEA, root cause analysis, Six Sigma, and Lean Manufacturing principles.

• Excellent problem-solving skills, attention to detail, ability to work under pressure and in a fast-paced environment.

• Effective communication (written and oral) and interpersonal skills for collaboration with internal teams and external stakeholders.

• ASQ Certified Quality Engineer (CQE) or Six Sigma certification is a plus.

• ISO/ASQ Auditor certification a plus.

Pay and Benefits

The pay range for this position is $35.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Dallas,TX.

Application Deadline

This position is anticipated to close on Mar 3, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.