Quality Engineer

Quality Engineer - Contract - Phillipsburg, NJ - $43.27 - $43.27/hr

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Quality Engineer in Phillipsburg, NJ

Role Description

Quality Engineer leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. The Senior Quality Engineer is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation.
Quality Engineer acts as the key contact working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met as well as hosting and managing customer audits, certification/surveillance audits as well as the internal audit program. He/she works collaboratively with other departments in both a leadership and participative manner to integrate the necessary systems.

Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements
Leads customer complaint investigations requiring direct interaction with customers as well as raw material suppliers
Manages and leads audit activities within the site including GMP, regulatory, customer and internal audits; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirements
Performs internal audits at other sites and may participate in supplier audits as required
Responsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actions
Ensures facility cGMP compliance is maintained and identifies/implements improvement programs as required
Provides GMP and GDP training to site personnel
Leads efforts to drive improvement efforts in global metrics with specific focus on complaints and complaint response time as well as CAPAs
Works with and provides input to Management of Change process
Performs statistical evaluations for processes and trending and leads validation activity associated with new products or changes to existing processes and products
Works collaboratively with supplier quality personnel to identify and resolve quality related issues impacting site performance as well as customer complaint
Partners collaboratively with external customers, operations leadership, and interacts with all levels of plant operations, R&D, procurement, commercial and quality teams
Works with all departments to investigate and resolve process and product quality issues
Performs other duties as assigned with or without accommodation

Skills & Requirements

Excellent writing and presentation skills
Demonstrated ability to accomplish goals through others
Demonstrated familiarity with chemical nomenclature and Quality Control testing and methods
Ability to merge divergent into an effective and efficient cross-functional team
Highly detail oriented with demonstrated strong analytical and problem solving skills
Ability to navigate in a matrixed environment and work collaboratively in a team environment
Excellent organization and project management skills
Ability to interface effectively with people at all levels of the organization, from executive to production line
Minimum of five (5) years of experience in quality engineering or a related role required
Experience working within pharmaceutical, biotechnology and/or chemical environments required
Experience working within cGMP/ISO 9000 regulated environments required

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text .

Drug testing may be required; please contact a recruiter for more information.

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