Senior Quality Engineer (Wayne, NJ) Defined Term

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

J o b O v e r v iew

The Senior Quality Engineer is re s pon si b l e f or eff e cti v e e sta b lis hm e n t a n d m ai n t e n a n ce o f qu ality s y s t e m s. Leads efforts to sustain and enhance Quality Compliance, maintenance of quality systems, preparation/revision of QMS Procedures to sustain compliance.

This position is a Defined Term position for a period of one year.

Work location is Wayne, NJ where the position is 4 days a week onsite.

J o b Res pon si b i li t ies a n d E s s e nt ial D ut i e s

• Review Quality Manual to identify potential gaps in documented quality processes (including outsourced processes), procedures to ensure compliance to ISO13485:2016, MDSAP, and FDA Medical Device Regulations as applicable to CAHW, CADI, and Collagen businesses.
• Organize existing QMS procedures per QMS documentation hierarchy and ISO 13485:2016 Clause classifications to identify gaps and redundancies, as appropriate.
• Understand existing Quality Management System processes and procedures, identify improvement/simplification opportunities, and revise quality process / procedures to improve QMS effectiveness and efficiency.
• Compare and assess QMS procedures for similar processes in CAHW, CADI, and Collagen businesses and identify opportunity to synergize/integrate associated QMS procedures with goal to create effective and unified Quality Management System for Cardiac Assist Business
• Collaborate with Corporate Quality Team to understand expectation and plan to align with GETQMS initiative.
• Revise (create, modify, combine, obsolete) Quality Manual, QMS procedures to create an effective, efficient, and lean set of Quality Management System procedures addressing CADI, CAHW, and Collagen businesses.
• Review Quality System documents and records storage and archival practices (adobe signed documents and localized archival practices) to identify potential compliance gaps and make necessary changes to ensure compliance with ISO 13485 Document Control and retention requirements.
• C o mm un ic a t e , i n t e ra c t a n d c o o r d i n at e qu ali t y i m p r o v e m e n t e ff o r ts w ith M a nu fact u ri ng , Q A , R &D , a n d e ng i n ee ri n g m a n a g eme n t.
• I d e n tify a n d l e a d i m p l e me n t a ti o n o f n e w o pp o r t un ities f o r i m p r o v e me n t s t o wo rk p r o c e s s e s, a n d o t h e r ar e as as i d e n tif i e d .

Re qu i r ed K no w le dg e, S ki l ls a n d A b i l i t ies

• A bachelor’s degree in engineering, S cie n c e o r e qu i v a l e n t is r e qu ir e d . A M ast e r of Science in E ng i n ee ri ng , S cie n ce o r e q u i v ale n t is p r e f e r r e d . CQE ( C e r t ified Q u ality E ng i n ee r) o r CQA (C e r tified Q u ality Aud i t o r) is d e sira b l e .
• A m i n i m u m o f 5 y e ar s with specific hand on experience in creation/sustenance of ISO13495 certified Quality Management Systems along with experience in quality assurance, quality engineering or related functions o r a M .S . p l u s 3 y e ars of above-mentioned e x p e ri e n ce is r e qu ir e d .
• P r i o r ex p e ri e n ce working in an F D A r e gu lat e d medical device organization o r I S O 13485 c e r t ified o r g a n i z at i o n.

• M u st h a v e d e m o n str a t e d p r o ficie n c y in working with ISO 13485 or 21CFR820 based M Q u a l ity Management Sy s t em s and Medical Device Regulations .
• P r o j ect m a n a g e m e n t a n d l ea d ers h ip ex p erie n c e is r e qu ire d . P r e v i o u s e x p erie n ce s up e r v isi n g t e c hn icia n s a n d c o ndu cti n g a n d p artici p ati n g in F D A / c u st o me r / c o r p o r a te a ud its i s p r e f e r r e d .
• Excellent oral and technical writing skills with the ability to interface effectively and professionally across departments and at all reporting levels.
• M u st d e m o n str a te e ff e c ti v e i n fl u e n ci n g a n d c h a ng e m a n a g eme n t skills a n d d e m on stra te d ac h i ev e m e n ts in p r o c e ss i m p r o v e me n ts.
• Experience in 6σ Methodologies (Lean 6σ, DMAIC, DMADV) with be strong plus.
• K n o w l e dg e o f M icr o s o f t O f fice P r o du c t s s u ch as W o r d , Ex c e l o r e qu i v a l e n t s o f t w a re a pp licat i o n s is p r e f e rr e d .
• W o r k i n g k no w le dg e o f s tatist i cal a n a l y sis, t h e a b ili t y t o a n a l y z e a n d s o l v e c o m p lex p r o b l e m s, a n d t h e a b ility t o c om m un icate e f f e cti v e ly ac r o ss d e p a r t m e n t s. F a m iliari t y w i th a n al y t i cal s o f t w are a pp lica t i o n s is p r e f e r r e d .

The base salary for this position is a minumum of $100,000 and a maximum of $115,000 a year

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.