- Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601 and other regulatory standards.
- Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
- Perform Quality audits as required.
- Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, and process validation documentation.
- Monitor quality performance of the ExM sites through the development of key performance indicators
- Analyze data to identify risks and drive implementation of mitigation plans.
- Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures.
- Collaborate with External Manufacturers during regulatory audits and inspections.
- Support Supplier Quality projects and issues as needed
- Provide oversight during tech transfer and new product introduction activities.
- Have an oversight of quality relationship to manage change notifications, respond to SCARs, establish quality agreements, and maintain strong relationship with Private Label Partners.
- Provide guidance and interpretation for industry related regulations within the framework of organizational product and sustaining development processes.
- Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
- Other duties as assigned.
- B.S. in Engineering or associated scientific discipline.
- Minimum 5 years Medical Devices or Pharmaceutical experience in Quality or R&D Engineering position.
- DMAIC experience - preferred
- Certified Quality Engineer (CQE) - preferred
- Certified Quality Auditor (CQA) - preferred
- Proficient with Minitab.
- Coaching and mentoring skills.
- Proven ability to directly lead and/or co-lead multiple tasks and projects.
- Strong understanding of industry expectations in the areas such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
- Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).
- Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
- Working knowledge of electro-mechanical devices, software validation methods, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred.
- Ability to interpret mechanical drawings.
- Familiar with gage and inspection techniques.
- Strong collaboration, negotiating, and conflict resolution skills.
- Fluid verbal and written communication skills.
- Travel up to 30%
-
External Manufacture Print Coordinator
2 weeks ago
MSD Malaysia Rahway, United StatesExternal Manufacture Print Coordinator page is loaded · External Manufacture Print Coordinator · Apply · remote type · Hybrid · locations · NLD - North Holland - Haarlem · time type · Full time · posted on · Posted 5 Days Ago · job requisition id · R293496 · Job Desc ...
-
External Manufacture Print Coordinator
2 weeks ago
MSD Malaysia Rahway, United StatesExternal Manufacture Print Coordinator page is loaded External Manufacture Print Coordinator Apply remote type Hybrid locations NLD - North Holland - Haarlem time type Full time posted on Posted 5 Days Ago job requisition id R293496 Job DescriptionJoin our team In Haarlem as an E ...
-
Bristol Myers Squibb New Brunswick, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Manager, Supply Chain External Manufacturing
6 days ago
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Synkriom New Brunswick, United StatesJob Description · Job DescriptionExperience: · • 3 or more years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies · • Experience with analytical methods and/or laboratory opera ...
-
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Bristol-Myers Squibb Summit, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Bristol-Myers Squibb Summit, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Bristol-Myers Squibb Summit, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Manufacturing Engineering Manager
3 weeks ago
Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Princeton, United StatesTHE JOB OPPORTUNITY: · The Manager will lead the Instrument Operations technical group that is responsible for i-STAT 1 hardware system on market support. In this role the Manager will ensure that processes and staffing are appropriately developed and implemented, set strategic v ...
-
Senior Biochemistry Consultant
3 weeks ago
Kelly Science, Engineering, Technology & Telecom Princeton, United StatesKelly Science is seeking a Senior Chemistry Consultant for a contract position for a growing company located near Princeton, NJ. The Senior Chemistry Consultant with be responsible for assay validations, method transfers and quality control testing of biological products. · Empl ...
-
Senior Auditor
2 weeks ago
WatsonBarron Group Princeton, United States Full time RegularSenior Auditor · Location: New Jersey or New York City · Travel: Varies 0-50%, depending on industry* · Salary: $95K to $125K plus bonus · Would you like to enhance your risk management and audit skills? If you are interested in continuing your career in the New Jersey or NYC a ...
-
Packaging Engineer
22 hours ago
Dr. Reddy's Laboratories Princeton, United StatesAt Dr. Reddy's "Good Health Can't Wait" · By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to help ...
-
Associate, Quality Compliance
3 weeks ago
SUN PHARMA Princeton, United StatesJob Summary · Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, labor ...
-
Production Technician
2 weeks ago
MyKelly Princeton, United States Full timeReady, set, go Put your career in motion with a great, new opportunity. Join the Kelly Professional & Industrial team as a Production Technician with one of the best industries in the world for sustainable energy. · Why you should apply to be a Production Technician. · l Pay Rat ...
-
GPV Case Management Product Specialist
3 weeks ago
GForce Life Sciences Princeton, United StatesSummary · Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing. · Description · Monitor and manage the ICSR ...
-
Senior Associate, QA Quality Compliance
3 weeks ago
SUN PHARMA Princeton, United StatesJob Summary · Responsible for batch certification review of site QA activities related to QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, e ...
-
Director, Legal Counsel
6 days ago
Genmab Princeton, United States Full timeAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
SMA Investment Operations Analyst/Associate
2 weeks ago
BlackRock, Inc. Princeton, United StatesTake the lead as an intermediary between brokers and sponsors to settle trade inquiries. Provide strategic support for industry-wide changes that involve proper trade allocations and settlements. Collaborate with internal and external business partne Operations Analyst, Operation ...
Sr. Quality Engineer External Manufacturing - Princeton, United States - Integra LifeSciences
Description
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
SUMMARY OF POSITION:
This position is for a Sr. Quality Engineer, External Manufacturing with hands on experience and proven success in providing quality leadership and technical support to ensure robust quality systems at the external manufacturing sites. This position will have the oversight in the selection and qualification of the ExM sites.
The candidate will work closely with commercial manufacturing team members, and ExM/Contract manufacturing leadership and maintains knowledge of current GMP expectations to define and drive Commercial QA objectives, strategies, and solutions to achieve these goals. The position will also have some oversight of managing supplier quality for the direct material suppliers.
The candidate will have demonstrated proficient experience with quality engineering concepts, including but not limited to design control, risk management, supplier quality, and continuous improvement. The candidate must also demonstrate consistent good decision-making skills and will have the experience to proactively identify and lead business development opportunities or address issues outside of their core responsibilities with minimal supervision. Additionally, the candidate will possess the critical behavioral skills integral to developing and strengthening productive relationships/partnerships.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law ) | EOE including Disability/Protected Veterans )
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA ) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at or call us at
Integra - Employer Branding from Integra LifeSciences on Vimeo )