Corporate Quality Engineer

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!
The Corporate Quality Engineer is responsible for being a quality leader within the product development core teams. This role ensures the lifecycle of product quality is linked between new product development and post market activities.
The incumbent will use Design Control and Risk Management tools to ensure designs are properly transferred into production that are appropriate for its intended use, identify and mitigate risks, and to provide input into the development of manufacturing processes.
The Corporate Advanced Quality Engineer will support company policies and procedures, goals and objectives, FDA regulations, good manufacturing practices, while cultivating an environment of excellence when dealing with internal and external customer relations.
This role ensures our new products meet and/or exceed agency and internal standards.
? 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
? Perform 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.
? Utilization of Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
? Supports the development of quality engineering and quality compliance with the right skill sets for product life cycle management.
? Review/analyze whether current product and processes (including actions or decisions conducted) are compliant to standards, such as the QSRs, ISO 13485, etc.
? Conduct investigation, bounding, documentation, and review of non-conformances, CAPAs related to customer complaints.
? Support, review and approval for process validations (IQ, OQ, PQ), TMV, equipment or software validations related to customer complaints
? Partners with PDI/Nice Pak Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management for complaints corrective actions.
? Interact and communicate with contract manufacturers producing our products in the form of complaint notification, resolution and investigation requests
? 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.
? Partners with the regulatory team to ensure complaint reportability is performed according to regulations
1. Timeliness completion of intake and complaint closings
2. Data Analysis and complaints trending
3. Continuous improvements events
4. Successful new product introductions, without any post launch negative customer experiences
A minimum of a Bachelor?s Degree or equivalent experience, preferably in Engineering or related technical field.
Medical and/or Pharma industry experience with 21 CFR QSR 820 Design Controls, and/or 21 CFR 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.
Must possess effective and diplomatic written and oral communication skills.
Proficient computer skills in a Microsoft Windows environment, with specific interest in Excel
Minimum of 2 years working within new product development cross sectional teams
Experience with Corrective and Preventive Actions in a quality system environment and regulated Industry
Ability to collaborate cross functionally as well as externally
Ability to identify trends
Analytical/ problem solving aptitude
Ability to resolve issues of conflict in a tactful and professional manner and to effectively management of unsatisfied customers
Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions.
Well-constructed job descriptions are an integral part of any effective compensation system.
All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined
to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by
supervisors as deemed appropriate.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or
others or which impose undue hardships on the organization.
Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.

  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.

  • Please view Equal Employment Opportunity Posters provided by OFCCP

  • 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)

  • Please refer to the Company?s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.


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