Job Title: Manager, Quality Assurance Engineering
Reports To: COO / dotted line to CEO
FLSA Status: Exempt
Summary: Plans and conducts activities concerned with the quality assurance of the OpitScanner device(s) and Disposable Cartridge. Directly responsible for all product test protocols and reports related to new product development and used to support regulatory submissions.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Management Representative
- Ensures adequate product test plans are developed and executed in accordance to internal and external design requirements (21CFR820, ISO 13485: 2012, applicable ISO standards, IEC, UL, ANSI, CLSI and other applicable standards)
- Develops appropriate test plans for ensuring a safe and effective product design. Ensures product design test sampling plans are adequately supported with the appropriate scientific rationale and justification
- Works with project members to develop design verification and validation plans, protocols, final reports, risk assessments and trace matrix. Will serve as an approving authority in the QA department for such reports
- Evaluates design and / or process changes in context with risk hazards analysis specific to the device and the software as well as FMEA, DFMEA and PFMEA as appropriate
- Performs quality engineering reviews of design documentation including Requirements, Design, Development, Implementation, Verification, Validation and /or Release Phase Reviews as needed
- Familiarity with shelf life, packaging validation and operating conditions testing a plus
- Supports the management review process
- Supports System Safety, EMI and EMC testing
- Supports design validation (human factors) via test protocol generation and requests for quotes
- Experience with internal and regulatory (FDA, FDB, ISO) audits required, preferably as a lead
- Implementation of continuous improvement measures
- Supports Technical File submission
- Supports 510(k) submission
- Maintains a working knowledge of government and industry quality assurance codes and standards (UL, IEC, ANSI, FDA, and ISO) and ensures team members are updated on changes.
- Works with marketing and/or document to create system labeling as appropriate
Knowledge, Skill and Competency Requirements:
- To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:
- 7 or more years experience in a medical device company in a quality assurance position with increasing responsibility.
- Product experience with a plastic disposable a plus (Class II or III). Capital equipment experience also preferred.
- High level of understanding in fluidics a plus. Also a general understanding of blood chemistry is preferred.
- Practical team experience as a QAE covering all phases of development from concept to requirements, design. Implementation, verification, validation, release, maintenance and obsolescence of a product.
- Experience applying the DMAIC process a plus. Green or black belt certification preferred.
- Practical knowledge in applied statistics (ANOVA, t test, SPC, sample size calculation, process capability).
- Excellent written and oral communication.
- Excellent knowledge of Microsoft Office Applications (Project, Power Point, Excel, Word).
- Ability to work quickly and with a wide variety of individuals, as a team member, and to juggle more than one task at a time as a manager.
- Knowledge of FDA Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and ISO 13485-2012 is required.
BA/BS or MA/MS – Chemistry, Biochemistry, Engineering or related field.
The QA manager will supervise individual contributors within the department.
The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure. The employee shall also receive general training in both 21CFR 820 and EN13485 as well as the OptiScan Quality Manual and Quality Policy.
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
If you are interested in applying to an open position at OptiScan, please email your resume to [email protected]