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Senior Advanced Quality Engineer Tru-D

Pdi

This is a Full-time position in Memphis, TN posted June 6, 2021.

Description Driven by a commitment to research, quality and service, PDI, Inc.

provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness.

Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE The Corporate Quality Engineer will support and assist with the development of company policies and procedures, goals and objectives, regulatory activities and good manufacturing practices while cultivating an environment of excellence when dealing with internal and external customer relations.

This position is the primarya quality leader within the product development core team for Tru-D SmartUVC.

This role ensures the lifecycle of product quality is linked between new product development and post market activities and ensures both new and existing products meet and/or exceed agency and internal standards.

The incumbent will work with contract development and manufacturing partners of Tru-D SmartUVC.

The proper use of Design Controls and Risk Management tools will be reviewed with each partner to ensure designs are properly transferred into production that are appropriate for intended use, identify and mitigate risks, and to provide input into the development of manufacturing processes.

ESSENTIAL FUNCTIONS AND BASIC DUTIES
– Supports the development of quality engineering and quality compliance with the right skill sets for product life cycle management.

– Quality leader in the New Product Development process to ensuring safe, effective, and reliable products are introduced to the market.

– Ensure the product meets and exceeds agency and internal standards over the life of the product.

– Develop predictive models to estimate failure levels.

– Investigate, develop, and validate product changes to drive improvement.

– Provide oversight for development and manufacturing partners in the performance of risk analyses based on design/reliability of product (i.e.) Process and Design FMEA.

– Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

– Review/analyze whether current product and processes (including actions or decisions conducted) are compliant to standards, such as the QSRs, ISO 13485, etc.

– Communicate with manufacturing partners to coordinate investigations completion for non-conformances and/or CAPAs related to nonconforming events and/or customer complaints.

– Coordinates with development and manufacturing partners to ensure appropriate application of process validation, process control, and risk management for process or complaint corrective actions.

– Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements.

– Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

– Act as a liaison between the business and its consumers.

Ensures relevant data is accurately captured in order to provide meaningful feedback to the business.

– Partner with a regulatory team to ensure complaint reportability is performed according to regulatory requirements.

– Provide coordination between development partners, manufacturers and SQA audit team.

– Monitor and track audit corrective action plans
– Conduct supplier audits (routine and/or ‘For cause’)
– Develop and maintain SOPs and policies
– Utilize electronic systems for documenting, tracking, and reporting activities.

– Provide various product teams with compliance evaluations of suppliers.

– Recommend approved suppliers for various commodities or projects.

– Assist procurement department and site quality departments for supplier risk assessments, ratings, and scorecard activities.

– Report internal department and supplier audit metrics.

– Other duties as assigned.

PERFORMANCE MEASUREMENTS
– Successful new product introductions, without any post launch negative customer experiences.

– Timely completion of complaint intake and closings.

– Data Analysis and complaints trending.

– Continuous improvements events.

– Values-centered execution.

– Training and certification compliance.

QUALIFICATIONS EDUCATION/CERTIFICATION:
– A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.

REQUIRED KNOWLEDGE:
– Medical industry experience with 21 CFR QSR 820 Design Controls, ISO 13485 and/or 21 CFR 11/210/211.

– Knowledge of ISO 14971 Risk Management
– Relevant experience working in manufacturing/operations is required.

Good technical understanding of manufacturing equipment and processes is required.

– Experience working in both an FDA and European regulatory environment is preferred.

– A thorough understanding of GMP/ISO and validation regulations is helpful.

– In-depth knowledge of product/process Risk Management (FDA and ISO standards) and a consistent track record of implementing risk mitigation is preferred.

– Knowledge of Six Sigma, Kaizen, Lean Techniques preferred.

Must possess effective and diplomatic written and oral communication skills.

– Proficient computer skills in a Microsoft Windows environment, with specific interest in Excel.

– Working knowledge of Electronics and/or 3D-Modeling software preferred.

EXPERIENCE REQUIRED:
– Minimum 7 years of experience in a regulated industry (FDA and medical device background preferred) with 3 years in a cGMP audit role.

– Minimum of 2 years new product development experience.

– Prefer a candidate which has both pharmaceutical and device experience.

– Working knowledge of 21 CFR 210, 211, 820, ICH, ISO 9001, 13485, 22716
– MDSAP implementation and maintenance experience preferred.

– Experience with Corrective and Preventive Actions in a quality system environment and regulated industry.

SKILLS/ABILITIES:
– Expert knowledge of the GMP Quality System and regulatory requirements in accordance with ISO Standards (FDA experience preferred).

– Ability to collaborate cross-functionally and externally
– Must be able to apply sound risk management.

– Ability to identify trends
– Excellent problem-solving skills based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments.

– Ability to resolve issues of conflict in a tactful and professional manner and to effectively manage unsatisfied customers.

– Must have expertise in interdisciplinary areas of engineering, operations, validation, cGMPs and regulatory issues.

– Strong written and verbal communication skills with all organizational levels and external partners.

WORKING CONDITIONS
– No hazardous or significantly unpleasant conditions.

– Standard office environment.

– Must be able to sit in front of a computer for extended periods of time.

– Must be able to travel at least 25%.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

41 CFR 60-1.35(c)

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