Senior Quality Engineer

As the Senior Quality Engineer you will be respons i ble for meet i ng customer requ i rements for the manufacturing of surgica l instruments and i mp l ants or i nstrument del i delivery s y stems from receiv i ng raw mater i al to the sh i pp i ng of fin i shed goods .

You will support and enforce the deve l opment of i nternal s y stems and procedures to meet I SO standards and FDA qua l i ty s y stem regu l at i ons . You will deve l opand implement i nspect i on / val i dat i on techn i ques necessary to verify products meet requ i rements at ear l iest po i nt i n the production process .

You will s pecify and i mp l ement ne w i nspect i on equipment and i nstructs others i n i ts proper use . You will s upportand i mp l ement s y stems in the areas of SPC , advanced qua l i ty , and des i gn/development.

• Assists in the deve l opment and implement at i on of s y stems and processes that foster continuous i mprovement for product deve l opment and / or manufacturing .
• Respons i ble for ensuring cell processes are correctl y base-l i ned & controlled . Kno w n var i ab il ity i s to be accounted for through selection & frequenc y of inspection , sampl i ng p l ans , or i mp l ementation of SPC .
• Completes the implement at i on and performance of gage R&R , process capabil i ty stud i es , design of e x per i ments , and summar i es as required to improve qual i ty and to prov i de required de l iverab l es to customers .
• Ensures processes re l eased w i thuse of SPC w here appl i cab l e and / or promote the util i zat i on of SPC .
• Prov i des SPC & ongo i ng monitoring of SPC .
• I nvestigates deviat i ons , OOS , complaints , returns , recalls , and fie l d alerts .
• Supports the M ater i al Revie w Board (M RB) for interna l non-conformances and customer returns .
• M a y lead or ver i fy effectiveness of corrective and prevent i ve actions ( CAPAs) .
• Ma y l i aise directl y w i th customer representatives .
• Supervise and tra i n personnel i n the inspection of ra w mater i als , i n-process and finished goods b y using statistica l samp l ing techniques and prec i s i on measuring i nstruments to chec k conformance to requirements .
• Verify that all product i on procedures have been follo w ed and the records such as Dev i ce M aster Records and Dev i ce H i sto ry Records are ma i ntained per FDA & customer requirements and Paragon M ed i cal requirements .
• Design i nspect i o n/ val i dat i on steps to be ta k en b y operations at the po i nt of manufacture and i ntegrate these steps into the manufactur i ng instruct i ons .
• Respons i ble to create , i mp l ement and i mprove qua l i ty s y stems and procedures for meeting I SO 13485 , FDA and customer qua l i ty s y stem requ i rements .
• W or k in conjunction w ith Cell L eaders to ensure C N C M achinists are k no w l edgeable and competent i n the use and care of sensitive measuring equ i pment and related requ i rements such as ca l ibrat i on , record i ng of data , e x pected var i ab il ity , etc .
• Prov i de da y
  -to-da y oversight of qual i ty including batch testing , i nspect i on , ca l ibrat i on , environmenta l monitoring , qua l ificat i on , document revie w , etc .
• Creates and supports EC N ' s and SCR ' s ( product ).
• M a y author i ze , i n i t i ate and / or approve product and process changes .
• Supports both interna l and externa l audits of all corporate qua l ity s y stems and demonstrates compl i ance through objective ev i dence .

• Preferred Bache l ors Degree i n Eng i neering or re l ated field

• 3-5 y ears e x per i ence w ith tight tolerance measurement s y stems i n mach i n i ng app l ications , b l uepr i nt read i ng , G D &T , and a w or k ing k no w l edge of short-run process control methods , D OE , ISO standards , and F D A qual i ty s y stem regulations .

• Strong w r i tten and v erba l commun i cation s k i lls .
• E x cellent customer teaming and i nterpersonal aptitude .
• Strong computer s k ills i nc l ud i ng e x cellent W ord , E x ce l , P o w erPo i nt , and M initab s k ills .
• E x cellent organizational s k ills and attent i on to detail required .
• D emonstrates prob l em solv i ng s k ills , app l y i ng effecti v e , data-dri v en , m i sta k e-proofing concepts .
• Strong project management s k i lls required .
• E x cellent follo w
  -up s k ills requ i red .
• Indi v i dua l is able to w or k w i th l im i ted superv i s i on and acti v e l y participa t e i n a team-or i ented , continuous impro v ement , manufacturing en v i ronment.

Frequent sitting, occasional standing, occasional w a l k ing . U se hand / fingers to grasp / pinc h/ grip Occasional c l imbing ( sta i rs / ladders ) or ba l anc i ng. Occas i ona l s toop , k nee l , crou c h , or cra w l. Occasional operating of machine ry and / or hand po w er tools.