Manufacturing Quality Auditor Jobs

Additional functions not specifically outlined in this position description as directed by the supervisor/manager.

Six months’ experience in quality (preferred).

One year manufacturing experience (preferred).

Randomly reviews each step of the inspection process with operators to assure that correct procedures are understood and followed.

Support the company’s quality process when internal and external quality failures result in product being contained.

Observes workers using equipment to verify that equipment is being operated and maintained according to quality assurance standards.

Maintains files containing control plans, flow charts, ISIR, shippers, and certifications. Files all process drawings.

Performs a non-repetitive function of auditing incoming raw materials and auditing products at different operations within the plant.

Follows verbal and written instructions and blueprints to determine dimensions.

Enters amounts and types of rejects, daily production, and gauge calibrations into PC.

Writes scrap, green "On Hold" tags, and deviations.

Conducts in process audits, capability studies, gauge R&R, and dock audits.

Demonstrated track record of management experience in a quality or engineering function

Carry out management and supervisory responsibilities in accordance with the organization's policies and applicable laws

Oversee the Product Performance Testing lab. Ensure compliance to all product regulatory requirements. Maintain Lab Certification

Support PPAP process of all new products introduced to the facility, including: product performance, meeting cosmetic requirement, etc.

Oversee a high performing team of Quality Engineers, Lab Managers, hourly Technicians

Minimum of 8 years of quality or product development experience in a lean high volume manufacturing / assembly is required

Strong problem-solving and conflict management skills, with the ability to multi-task

Knowledge of constraint management principles

Create a conducive work environment for the team(s) to complete their assigned responsibilities and tasks

Basic administration of supervisory responsibilities and documents

Strong organizational and administrative skills

Candidate must be willing to work remotely and in-person at temporary facilities as needed during initial plant start-up phase

Owens & Minor teammate benefits include:

Medical, dental, and vision insurance, available on first working day

401(k), eligibility after 30 days of employment

Development opportunities to grow your career with a global company

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.

Currently enrolled in Bachelor's or Master's curriculum in Industrial Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, Materials Management, or similar discipline.

Operations related work experience could include components of production planning, material handling, and/or lean initiatives & process improvement studies.

The student will work on discipline-focused projects and tasks to enhance their collegiate learning experience, while providing meaningful contributions to PFF.

Must have excellent written and verbal communication skills

Provide strategic and tactical support to employees in the areas including quality inspection, logistics, production, and/or materials planning.

Contribute to the preparation and execution of key operational projects and tasks.

Education and/or Experience and Other Skills and Abilities:

Maintain daily communication with the Quality Manager in regard to trends and potential issues.

Assist the Quality Manager in supporting control of Quality System documentation and quality records.

1-3 years' experience; preferably in a prior quality position

Previous experience performing quality inspections.

Experience in a regulated industry is preferred.

Reviewing customer contracts to ensure specific requirements are met

5+ years of experience in a manufacturing environment

Must have working knowledge of ISO 9001

CQE or Lean Six Sigma certification

Oil and gas industry experience preferred

$85,000 - $105,000/year commensurate with experience

· Experience with equipment qualification processes, including IQ, OQ, and PQ, in a medical device manufacturing environment.

We offer a competitive compensation package to successful candidates.

· Provide guidance and training to manufacturing personnel on quality control methods, procedures, and best practices.

· Bachelor’s degree in engineering or a related field.

· Proficiency in process validation methodologies, including protocol development, execution, and report writing.

· Familiarity with statistical analysis tools and techniques used in quality control and process improvement.

Prepare well organized, easily understood reports, analysis, and summary of findings for use by management

Demonstrates problem solving and analytical skills.

Flexibility to learn and adapt to changes in procedures, techniques, and position requirements.

Develops and maintains knowledge of business policies and procedures, and assesses their impact to applications.

Works effectively in a team environment and supports the activities and success of others on the team.

Learns, comprehends, and applies information, both business and technical in a consistently satisfactory manner.

Lean Manufacturing, 6-Sigma, Project Management knowledge/skills

Requirements/Preferences: Education Preferred: Bachelor’s degree in an engineering related field

Experience Preferred in following areas: Manufacturing Engineering, Quality Engineering, Industrial Engineering (open to recent graduates)

Top Must Have’s: Manufacturing Related Experience (Manufacturing Engineering, Quality Engineering, Industrial Engineering) or BS Engineering

Computer Skills: Including CAD, Office Suite/Power BI

Education Preferred: Bachelor’s degree in an engineering related field

High school diploma, GED or education equivalent

Solid understanding and working experience of Microsoft Office Suite

Excellent communication skills; including written and verbal

Must be able to meet physical requirements of position which include extensive walking, with occasional bending and reaching

Successful completion of interview required to meet job qualification

Quality and Process Auditor experience preferred

Overseeing management of company-owned tooling calibration activities, ensuring seamless continuity

Ownership includes managing quality assurance and quality control for the plant. Lead RCA management, ensuring timely RCA resolutions

Responsible for Management of Change process and Change Control Board implementation

Ensure ISO re-certification & compliance

Overall responsibility for Internal Audit execution, for conformance to quality plans, systems, and requirements as per the Internal Audit Plan

Ensure adequate training/skills for quality engineers, internal auditors, quality control inspectors

Generates departmental metrics and reports to management

Advanced experience with data entry

1-3 years working in quality management systems and/or regulatory affairs

Manage External Audit data to ensure external audit reports and findings are recorded in PIL

Bachelor's degree, or equivalent experience

Basic experience with data analysis and research

Prepare various quality report for management review

Implement risk assessment and management of change in process

Drive Plant Quality performance metrics

Maintain compliance of the production site to all applicable regulatory, company and quality standards

Ownership of production related non-conformance, including Containment, investigation, and implementation of sustaining countermeasures

Operationalize QMS policies/procedures/WI/control for production operations

Experience with ISO9001/AS9100, FAA MIDO and FSDO quality management systems and auditing preferred

Lead and Perform audits of AS9100, FAA Certified Repair Station, customer and regulatory quality management systems.

Coordinate and preparation of Quality Management System reviews.

Facilitate and coordinate process improvement for Quality Management System and Enterprise Resource Planning. (ERP)

Participate in supplier management activities

Review customer requirements for applicability. Participate in project launches and program reviews.

Strong knowledge and experience in injection molding processes is highly preferred.

Experience with quality standards and regulations, such as ISO 9001 and/or other relevant certifications.

Stay updated on industry trends, advancements, and regulatory requirements related to quality engineering and injection molding processes.

Excellent problem-solving and analytical skills, with a keen attention to detail.

Strong communication and interpersonal skills to collaborate effectively with cross-functional teams and external stakeholders.

Ability to work independently and manage multiple projects simultaneously.

High school diploma, GED or education equivalent

Solid understanding and working experience of Microsoft Office Suite

Excellent communication skills; including written and verbal

Must be able to meet physical requirements of position which include extensive walking, with occasional bending and reaching

Successful completion of interview required to meet job qualification

Quality and Process Auditor experience preferred

10+ years of pharmaceutical quality experience in Aseptic processing & Environmental Monitoring required; 5+ years of management experience required.

Collaborates with corporate quality functions to ensure site compliance with the company’s Quality Management Systems (QMS).

Guides, instructs, and coaches members of management in compliance issues.

Expert knowledge of pharmaceutical regulatory requirements and cGMP required.

Ensures GMP compliance to regulatory requirements and Company procedures.

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Preferred background in Social/Human Services, Special Education, or Information Technology working with individuals with disabilities.

Executes local strategies for successful ongoing management of EMR software.

Chronic Disease management programs for hypertension and diabetes (for qualifying employees)

We offer the following benefits to employees:

Experience with Therap or other electronic health systems preferred.

Good written and verbal communication skills with excellent self-discipline and patience.