Quality Engineer- Gap Remediation

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Volt is immediately hiring for Quality Engineer- Gap Remediation in Warrendale, PA
As a Quality Engineer you will:

• Support CFR 820,MDD, technical services SOP gap analysis and remediation by identifying gaps, updating the QMS to address deficiencies, proposing corrections and additions to QMS documentation, and verifying implemented changes based on gap analysis outcomes.

• Supports the CAPA, Internal Audit, document control, complaint investigation, and other quality system processes to ensure conformance to applicable regulations, standards, and corporate policies.
• Updates and maintains QMS SOPs, work instructions, and forms based on interpretation of applicable quality standards, internal gap assessments, and audit findings to ensure ongoing regulatory compliance and audit readiness.
• Utilizes basic project management skills for timely completion of projects in support of plant goals.
• Assist in updating supplier quality files & performance scorecards with accurate, current documentation of supplier performance in alignment with requirements.
• Supports in-depth audits of Quality System elements against internal and external requirements including regulatory requirements, industry standards, regulatory guidance documents, corporate policies and standard operating procedures, and local procedures, documents, records
• Provide support for regulatory compliance processes such as Product Field Action assessments and execution.
• Collaborates with other departments and cross-functional teams on daily tasks and projects, such as CAPA records complaint investigations, and internal audit reports/ responses.
• Initiate and manage CAPA records and facilitate board meetings to ensure on-time completion & escalation as needed.
• Work cross-functionally to support investigations teams and root cause analyses and provide well-documented corrective and preventive action plans for identified issues
• Compiles, reviews, analyzes, and distributes monthly metric reports for CAPA, Internal Audit, Complaint Investigation, and other quality system processes to identify trends and potential process improvements.
• Ensures effective communication of audit activities, status and metrics to leadership throughout the organization
• Supports preparation for and hosting of external audits by regulatory agencies and notified bodies

This is a full-time- contract opportunity.

The Ideal Candidate will have:

• Bachelor s Degree in science or engineering field
• Previous Gap assessment experience
• Proficiency with Microsoft Word, Excel, and Power Point.
• Supplier file management
• CAPA execution
• 0-3 years experience in a medical device, pharmaceutical industry preferred.
• ASQ Certified Quality Auditor, Certified Biomedical Auditor and/or ISO 13485 Lead Auditor certification preferred.
• Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, MDD, etc.) preferred.
• Good verbal and written communication skills.
• Basic analytical, trouble-shooting, and problem-solving skills

PAY RANGE AND BENEFITS:

Pay Range*: $64 - $85 per hour

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please email or call . Please indicate the specifics of the assistance needed.

Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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