PURPOSE OF THE POSITION
The QA Supervisor role is to initiate and manage the implementation and maintenance of quality systems, and
coordinate quality initiatives with Operations, R&D, and Marketing management. Ensure proper quality levels are
being met for products according to any marketing, regulatory and ISO requirements. Develop quality teamoriented
employees that can respond to business and customer needs without compromising quality.
ESSENTIAL JOB FUNCTIONS
relavent regulatory or industry requirements, i.e. ISO 9001, ISO 13485. Have the abilities to act as a site
- Demonstrate leadership in developing, implementing and maintaining the quality management system to
Management Representative for the QMS
costs, and enhance programs within the Quality Management System.
- Work with other departments, facilities and business units to solve problems, improve service, reduce
system capabiliites including new or existing product opprotunties, complaints, product status, or quality
- Participate in conversations with customers, Marketing and/or Sales regarding the quality management
techncial/information system support.
- Contribute to aspects of ensuring product quality of raw and final products produced &/or repackaged to
management system that exhibit an opportunity for improvement (ex. Documentation management,
- Lead process improvement efforts within Quality Assurance. Recognize those areas of the quality
Complaints, Training, etc.) based upon business, customer, and regulatory requirements and develop,
implement, and maintain the Quality Management System to requirements.
process. Act as independent party, responsible for providing input on regulatory requirements and
- Participate in design, development, and approval of new products through the R&D Design Control
ensuring compliance to all internal policies and procedures.
to those objectives.
- With management establish performance metrics to support business objectives and monitor conformance
- Coordinate the selection, training, development, motivation, and evaluation of employees.
Education: B.S./B.A. in Life Sciences, Chemistry, Pharmacy, Chemical or Process Engineering and 6-8 years'
experience in industry or a non-science, 4-year degree with at least 15 years applicable Quality System (i.e. ISO,
diagnostics, medical device environment) experience in the specific QA job function as deemed appropriate by QA
Management, required. 1Advanced degree in Chemistry, Biochemistry, Biology, Pharmacy or Engineering and 4-6
years in industry, preferred.
submissions for medical device approval for CE marking and US submissions including 510(k), PMA
- 2-4 yrs. prior experience in managing personnel, required.
- Knowledge of ISO 9001 & 13485, required.
- Current diagnostic, medical device industry knowledge &/or experience, required.
- Knowledge of regulatory compliance for diagnostic, medical device, including understanding various
Annual Reports and Technical Document Files, desired.
Essential and Critical Skills:
Operations Management, desired.
- Strong leadership skills with a successful track record of personnel development, required.
- Basic budgetary planning, capital expenditure justification, and basic Finance, Accounting, Marketing, and
Powerpoint and ability to learn and operate using other specific application software (SAP, eDoc, etc.)
- Excellent computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS
Analysis, Root Cause Analysis, and Experimental Design, required.
- Excellent communication (verbal & written) and customer services skills required.
- Excellent writing skills and experience writing technical documentation & reports required.
- Ability to simultaneously manage multiple tasks/priorities required.
- Excellent problem solving skills/abilities including Pareto analysis, flowcharts, PDSA, Cause and Effect
ADDITIONAL LOCAL NEEDS:
- Good understanding of Validation, Qualification, desired.
- Good time management and negotiating skills required.
- Capacity for independent work required.
- Data analysis, presentation, and experimental design knowledge desired.
- Project management experience desired.
- Secondary language (Spanish, French, etc. ) skills desired.
Environmental conditions: 95% Office Environment, 5% Operations: Production, Labs, Packaging, and Warehouse
NOTE: some travel may be required
Physical requirements: Give site tours of facilities including use of stairs.
About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 35 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich, please visit its website at www.sigma-aldrich.com.
Sigma-Aldrich offers a highly motivational and rewarding working environment with attractive salary, benefits, retirement, relocation and incentive packages including tuition reimbursement. Sigma-Aldrich fosters the growth of employees in a culture of respect and dignity with ample opportunity for career advancement.
Sigma-Aldrich is an Equal Opportunity Employer
Check the shelves of any research (or mad) scientist and you'll likely find Sigma-Aldrich's chemical products. The company is a...