Sr Quality Engineer

Overview

Sr Quality Engineer Jobs in Brooklyn Park, MN at Cirtec Medical Corporation

Summary:

The Manager Quality Control and Assurance role is a mixture of hands-on from a technical point of view and hands-off with a focus on strategy and processes. Will oversee daily operation of the QA/QC department to ensure compliance to regulations and processes, will also take responsibility for ensuring all development tasks meet quality criteria through test planning, test execution, quality assurance and issue tracking. Working knowledge of OTC products, rules and regulations is a must since we are a 3rd party cosmetics manufacturing facility.

Essential Duties and Responsibilities:

· Determines QA Goals and Measurements systems with Management.

· Promotes and maintains quality achievement, performance improvement and positive team building through leadership in the organization.

· Ensures compliance with FDA, CADHA, Department of Treasury and international regulations including ISO and ICH guidelines and enforces good cGMP’s.

· Establishes and ensure processes are documented and followed.

· Maintains awareness of the business context and company profitability, including budgetary control issues.

· Assess the product specifications of the company and its suppliers, in comparison with customer requirements.

· Consideration and implementation of environmental and health and safety standards.

· Creates and monitors clearly defined quality methods for staff to apply.

· Defines quality procedures in conjunction with operating staff.

· Manages and maintains Quality Control Aspects such as manual testing, breaking test, in-house testing, related test methods of all incoming components, raw materials documentation procedures and bulk approvals.

· Identifies training gaps and coordinates accordingly.

· Supervises and ensures tests, checks and procedures are properly understood, carried out and evaluated, including product recall and market withdrawal.

· Ensures the execution of corrective action and compliance with customers’ specifications.

· Manage external and internal audit, monitoring of the plant, laboratories and third party contract facilities.

· Establish and/or manage standards, specifications for customers or clients as needed.

· FG Specs: ensure that project management provide necessary information for spec creation

· External Communications with clients, regulatory bodies, contract labs

· (SOPs) Standard Operating Procedures (review, update and revision)

· Audits: pre-audit questionnaires, overseeing audit as the face of company and response to audits with any potential corrective action

· NCR (Non-conformance report) / CAPA (Corrective and Preventive Action)

· Work Orders / Compounding paperwork (review and approve)

· Outside Labs Communication (Timing, Samples, Results, Costing)

· Oversee day to day activities of all other individuals in the department

· Monitor, generate and report of KPIs

· Maintains awareness of the business context and company profitability, including budgetary control issues. Directing objectives to maximize profitability

· Documents and appraises employee performance. Interviews and hires regular and temporary employees and recommends personnel changes and terminations.

· Define together with R&D and customer the process, documentation and all tests related to a new and existing OTC products.

· Other duties as assigned by the General Manager.

Supervisory Responsibilities:

This job has supervisory responsibilities.

Qualifications/Requirements:

· Extensive knowledge in OTC products

EDUCATION:

· Bachelor’s Degree in Chemistry, or other related field strongly preferred or

· Quality related certificate such as ASQ, CQA, CQE ect.

EXPERIENCE:

· Minimum of 5+ years experience in Quality Control.

· Strong Management experience.

· Strong written and verbal communication skills.

Strong with understanding rules and regulations of all OTC products.

KNOWLEDGE/SKILLS/ABILITIES:

Knowledge:

· Standard, clerical office practices and procedures especially as they relate to the function of this position.

· Working knowledge of MS Office, Word and Excel.

· Strong written and verbal communication skills, needed to effectively communicate with, Management, guests, customers, vendors, suppliers, etc.

Abilities:

· Speak and write effectively; prepare documents that are succinct, (priority, high area of interest), and grammatically accurate; correctly apply policies, procedures, and regulations. Work effectively in a diverse community; maintain confidences, and confidentiality. Attention to detail and the ability to work on multiple tasks simultaneously, is critical for the success of this position.

Physical Demands:

· The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.

Work Environment

· The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Special Requirements:

· Ability to work effectively with a diverse community.

Job Type: Full-time

Pay: $98,000.00 – $105,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Flexible schedule
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance

Schedule:

8 hour shift
Day shift
Monday to Friday

Ability to Commute:

Torrance, CA 90503 (Preferred)

Work Location: In person

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Title: Sr Quality Engineer

Company: Cirtec Medical Corporation

Location: Brooklyn Park, MN