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Manufacturing Change Control Specialist

San Diego, CA, United States

As a Change Control Specialist , you will be responsible for implementing and maintaining quality assessments for proves change notices/orders. You will lead validation, generating documentation for new manufacturing procedures, rolling out new equipment and managing the instructions on related new equipment. You will represent the manufacturing department on project team meetings, supporting product change and launch activities.

Who are you?

You are a highly driven and detailed individual that is comfortable managing multiple projects simultaneously. You enjoy working with process implementation, optimization, and updating associated documents. You are detailed with a proven ability to review documents for errors to ensure accuracy.

To be successful in this role , you will have a minimum of 5 years of experience with general manufacturing process flow and all related operational areas. You can identify and provide corrections for deviations from standard process, with familiarity with Lean Six Sigma and other continuous improvement programs. You have intermediate skills with Microsoft Office and Inventory Management systems. Prior experience with automation and medical device products is an asset.

If we just described you and you would like to learn more, please apply for immediate consideration.

About us:

At Sekisui Diagnostics, we help improve patient outcomes by doing what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.

Equal Opportunities

As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics, or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the Company's internal recruiting team.

Sekisui Diagnostics offers a competitive compensation and benefits package including a generous hourly rate, participation in annual bonus plan, Company match to RRSP, education and fitness reimbursements and paid time off to volunteer. The anticipated base compensation for this position is $84,000 - $94,000. This role may also qualify for annual incentives and/or comprehensive benefits. The actual base compensation offered will depend on a variety of factors, including without limitation, the qualifications of the individual applicant for the position, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location of the position.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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