07.09.15
: 4310BR
: Microbiologist
: Global Quality and Ops
: Orthopaedics and NV Global Supply
: North America Ops
: Quality Assurance
: United States
: NJ
Mahwah
: Full Time
: Up to 10%
: 1st
: Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
The Microbiologist will identify, isolate and study microorganisms and their byproducts as it relates to the manufacturing and sterilization of Stryker medical device products and will practice one or more of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat. The Microbiologist will also review biocompatibility tests and interpret the associated industry guidelines and will work with manufacturing operations and research groups to develop new products and support continuous quality improvement initiatives.
Specific responsibilities of the Microbiologist include, but are not limited to, the following:
Candidates should possess the following skills:
The following skills/experiences are all preferred:
: Microbiologist
: Global Quality and Ops
: Orthopaedics and NV Global Supply
: North America Ops
: Quality Assurance
: United States
: NJ
Mahwah
: Full Time
: Up to 10%
: 1st
: Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
The Microbiologist will identify, isolate and study microorganisms and their byproducts as it relates to the manufacturing and sterilization of Stryker medical device products and will practice one or more of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat. The Microbiologist will also review biocompatibility tests and interpret the associated industry guidelines and will work with manufacturing operations and research groups to develop new products and support continuous quality improvement initiatives.
Specific responsibilities of the Microbiologist include, but are not limited to, the following:
- Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin and biocompatibility analysis of orthopedic implants and surgical instruments
- Actively support new product development activities
- Participate in the development and improvement of the manufacturing processes for existing and new products
- May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ)
- Serve as the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects
- Support product transfers to other plants/facilities
- Review/approve nonconforming material and system documentation
- Review/approve product and process change control documentation and specifications
- Serve as a mentor to other team members
Candidates should possess the following skills:
- Ability to effectively work cross-functionally with Product Development, Operations and Marketing
- Demonstrated ability to manage workload
- Demonstrated ability to communicate effectively across different organizational levels
- Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team to ensure that all deadlines are met
The following skills/experiences are all preferred:
- A minimum of 2 years of applied medical device, pharmaceutical, and/or consumer products industry microbiological or biological testing, research and development or sterility assurance experience
- Understanding of the fundamentals of one of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat
- Demonstrated experience with biocompatibility tests and have the ability to interpret the associated industry guidelines
- Demonstrated competency in advanced testing technologies
- Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures
- Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives
- Hands on experience with equipment and/or process validation, especially clean room experience, is highly preferred