Job Title: Manager, Manufacturing Quality Control
Reports To: VP of Operations
FLSA Status: Exempt
Department: QA

Summary: The Manufacturing Manager, Quality Control plans and conducts activities related to Manufacturing Quality Control including: incoming inspection of components, production quality control, supplier quality, customer complaints, failure investigations, CAPA’s and NCR’s, internal / external audit functioning, product release, environmental monitoring, sterilization quarterly dose auditing. Also responsible for facilitating Management Review meetings and presenting key quality metrics to Senior Management.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

•  Responsible for receiving inspection of all materials received (Instruments and Disposables).
•  Responsible for In-process inspection using Statistical Process Ensure on time corrective action/s to processes outside of the
specified control limits.
•  Administration of the Customer Complaint, CAPA, Failure Investigations, NCMR and Deviation systems
•  Ensures adequate inspection methods are executed and maintained in accordance to internal and external design
requirements (21CFR820, EN13485, applicable ISO standards, IEC, UL, ANSI, and other applicable standards).
•  Develops best sampling plans for incoming inspection and ensures sampling plans are adequately supplied with the
appropriate scientific rationale and justification.
•  Reviews and approves ALL manufacturing changes including those made to raw material, assembly and final product
specification. Also ensures each change has the appropriate level of documented testing and justification.
•  Ensures assigned supplier CAPA’s are addressed and closed in a timely manner.
•  Ensures all equipment and tooling used to manufacture, assemble or test product or components has been validated.
•  Works closely with purchasing and engineering to qualify appropriate suppliers.
•  Applies the appropriate statistical method when analyzing data to evaluate the current process and or proposed process
changes. Trends and publishes such data and as necessary, initiates corrective and preventive action.
•  Maintains a working knowledge of government and industry quality assurance codes and standards (UL, IL, ANSI, FDA, and ISO).
•  Responsible to maintain the Device History Record (Instruments & Disposables).
•  Responsible to conduct internal and external quality and supplier audits.

Knowledge, Skill and Competency Requirements:
To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

•  7+ years experience in a medical device company in a quality assurance position with increasing responsibility
•  Knowledge of FDA Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and ISO 13485-2003 is required
•  Excellent verbal and written communication skills and ability to collaborate across functional teams
•  Experience managing teams and ractical team experience as a QAE/supervisor covering phases of concept, feasibility, development
and production is required
•  Product experience must include plastic disposables (Class II or III). Capital equipment experience preferred
•  High level of understanding in fluidics is expected. Also a general understanding of blood chemistry is highly preferred
•  Must have experience applying the DMAIC process. Green or black belt certification preferred
•  Practical knowledge in applied statistics (ANOVA, t test, SPC, process capability)
•  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 manage multiple tasks simultaneously

BA/BS or MA/MS – Chemistry, Biochemistry, Engineering or related field.

Supervisory Responsibilities:
This job will supervise incoming and in-process inspection/inspectors as well as technicians responsible for product and environmental testing and or failure analysis.

Required Training:
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]