Avantor, Inc. Sr Supplier Quality Engineer in Devens, Massachusetts
Job SummaryThe Supplier Quality Engineer will act as the quality subject matter expert on cross-functional project teams to determine and conduct activities to assist in qualifying new suppliers. These activities include assessing quality system information for new suppliers through questionnaire review and auditing (both GMP and Non-GMP), assessing and tracking supplier action plans, working with the purchasing team to negotiate Quality Responsibility Agreements with suppliers to ensure expectations are mutually understood and agreed upon, and reviewing and approving material specifications. The Supplier Quality Engineer will also support maintenance of existing supply base through review and approval of change control documentation and material specification revisions, periodic supplier quality system assessment, participation in Quality Responsibility Agreement negotiation, and in supplier nonconformance investigations.
MAJOR JOB DUTIES AND RESPONSIBILITIES:
Assess potential suppliers for manufacturing, technical, and quality capabilities versus specifications and quality expectations.
Identify and recommend solutions to improve the supplier qualification and management process and system.
Interface with purchasing on supplier development.
V e r i f y c o m p l i a n c e t o purchase orders a n d p r o ce s s c o n t r o l s t h r o ugh s i t e a ud i t s or desk audits o f e x i s t i n g s up p li e r s .
Schedule, conduct, and comp l e t e s up p li e r q u a l i t y s y s t e m a u d i t and audit reports .
Works with suppliers to develop corr ec t i ve ac t i o ns f r o m a u d i t f i n d i ngs a n d d r i v e s c o m p l e t i o n o f t a s k s .
V a li d a t e e ff ec t i v e n e s s o f S C A R r oot ca u s e s t h r o ugh o n - s i t e v i s i t s to s upp li ers.
Fac il i t a t e s r e s o l u t i o n o f p r o b l e m s r e l a t e d to mi s u nd e r s t a n d i n g o r mi s i n t e r p r e t a t i o n o f p r o du c t s p e c i f i c a t i o ns.
Part i c i p a t e s i n p r o j ec t t e a m m ee t i n gs to e n s u r e qu a l i t y a n d o p e r a t i o n a l p r o ce du r e s a n d r e q u i r e m e n t s a r e c l ea r ly u n d e r s t o o d and communicated to the supplier .
Pro v i d e s t ec hn i c a l i nput f o r s t r a t e g i c s o u r c i n g p r o j ec t s , i n c l u d i ng e v a l u a t i o n o f s up p l i e r ca p a bil i t y , s p e c i f i c a t i o n r e v i e w, p r o du c t im p l e m e n t a t i o n a n d product t r a n s i t i o n .
Works c l o s e l y w i t h a pp r o p r i a t e purchasing lead to monitor s up p l i e r p e r f o r m a n ce .
Liai s o n b e t w ee n QC i n s p e c t i o n a n d s up p l i e r r e g a r d i n g i n s p ec t i o n of s upp li e d p r o du c t .
Work with suppliers on process improvement and value enhancement opportunities.
Resp o n d w i t h a h i g h se n s e o f u r g e n c y t o qu a l i t y i s s u e s a n d e s c a l a t e / c o m m u n i c a t e a pp r o p r i a t e l y .
Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications):
BS Degree in Engineering, Life Sciences or another closely related technical discipline is preferred; or equivalent combination of applicable experience
5 -7+ years of applicable experience
American Society of Quality (ASQ) certification as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) and/or Six Sigma Green Belt or Black Belt strongly desired.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Knowledge of the principles and practices of Quality Assurance in the consumer, pharmaceutical, or medical device industry is required.
Knowledge of GMP requirements and current FDA enforcement regulations is preferred.
Pro f icient in quality analysis t ools such as Fishbone, 5-why’s, SP C , PFMEA etc. S t r o ng p r o blem s o lving s k ills with ab i lity to teach basic problem s o lvi n g techn i ques and f acilitate problem solvi n g team e v ents.
Expe r i ence in de v e l o ping product certi f icati o n processes a n d vendor q uality m easures.
St r ong engineering anal y sis, computer, communication, presentation and team skills
Strong data a n al y s is and reporting s k ills
Knowledge of Quality System, FDA, ISO regulations, CAPA system, GMP practices.
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions):
The work environment characteristics and physical effort described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the associate is exposed to an industrial warehouse environment. The associate works near moving mechanical machinery and noise level in the work environment is usually loud. The job requires working in heights, exposure to changes in temperature, driving equipment, and maybe exposed to dust, fumes, or gases. The associate is required to stand and walk for the majority of the working day. The physical requirements of the job are for associates to talk, hear, bend/stoop, squat, crawl, climb height, reach above shoulder height, crouch, kneel, balance, and push/pull. Furthermore, the job requires associates to lift/carry/push or pull up to 75 pounds with or without assistance. Associates use both hands for repetitive actions such as grasping and manipulating as well as both feet for repetitive movement operating foots controls. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus. In addition:
Each employee is responsible to perform their defined tasks in order to maintain the site’s certifications and comply with all regulatory requirements. The employee is expected to shut down the operation and notify management if an unsafe condition is observed or an instance of regulatory non-compliance that requires immediate attention arises. Regulatory requirements include, but are not limited to cGMPs, EPA, OSHA, DEA, DOT, and any other applicable local, governmental and company guidelines
Meet minimum training requirements for RCRA Hazardous Waste Management (40 CFR 262.17(a)(7)) within 6 months of employment, and re-train as required by the Kentucky DEP and US EPA hazardous waste regulations
DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.
EEO is the Law (https://media.vwr.com/emdocs/docs/EEO-is-the-law.pdf)
OFCCP EEO Supplement (https://media.vwr.com/emdocs/docs/OFCCP-EEO-Supplement.pdf)
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
3rd party non-solicitation policy
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation
Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world. For information visit, www.avantorsciences.com and find us on LinkedIn (https://www.linkedin.com/company/avantorinc/) , Twitter (https://twitter.com/Avantor_News) and Facebook (https://www.facebook.com/Avantorinc/) .
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