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California - Poor work culture - Manufacturing California

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  • California - Poor work culture - Manufacturing California

    Hello!

    My husband is employed (salary, exempt) as a Quality Assurance & Regulatory Affairs Director at a small family-owned manufacturing company for medical devices (about 15 employees). He has been there 10+ years. I used to be employed there as well so I am familiar with the company, and until a few years ago I maintained a career in the same industry. They are regulated by the Food & Drug Administration (FDA) under Code of Federal Regulations (CFR) Title 21 Part 820 (Quality System Regulation), as well as the Department of Transportation (DOT) and the Nuclear Regulatory Commission (NRC) as they manufacture and distribute devices used in cancer radiation therapy. The radioactive manufacturing takes place at a satellite facility in Louisiana, but it is managed out of my husband's office in Los Angeles County.

    I feel compelled to disclose that I was fired from this company for "misplacing records," but I have always been suspicious that I was fired for dating my husband while we were employed there; we had just broken up a couple months prior, but we ended up back together and I got a better job so Happy Ending!

    There are several problems going on, most of them being (in my opinion) recurring, but my husband is afraid of saying anything and losing his job because he is in his mid-fifties and believes that puts him at a disadvantage in the job market should he quit or be fired. He also does not have a degree, and has moved up solely through his work experience and he believes that also puts him at a disadvantage. I also think he believes he owes some sort of sentimental debt to the company because that's how we met.

    1.) He is working in a culture of non-compliance. He is asked to fudge records on a regular basis, i.e. back-dating, making stuff disappear when auditors from the FDA and the state arrive, etc. I believe he was keeping records of these activities, but I am not positive. The company has had fines and other penalties from the Department of Justice (DOJ) on behalf of the DOT & DOE for falsifying records and one of the family members (brother of the current CEO and then-COO) was fired as a condition for the company keeping their license and received a felony. There is also documentation relating to this incident stating that the work culture permitted employees to break the law in service of the company or something to that effect. I am told the CEO openly offers his frustration and distaste for federal regulation of his company.

    2.) Many of the employees are incompetent, and my husband is required to build into their quality systems and processes work-arounds for each incompetent employee and/or department because "[CEO] doesn't like to fire people because it makes him anxious" (I was fired by the brother that was fired). I pointed out to my husband that 21 CFR 820.25 Personnel states that "each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed." Based on my education & experience, this means incompetency is fired. Examples of incompetency include: claiming they were not trained on procedures in spite of signed training records and elaborate training sessions tailored to these individuals; unable to perform tasks as described in their job description & resume and having my husband do their work or hire outside consultants to perform their job; complete disregard for regulations and an "I don't care, not my job" attitude. As such, my husband is approached by CEO to "fix it" and his work-load increases far beyond the scope of his job description, including engineering-type functions for which he is not formally quaified.

    3.) Constant verbal hints, jabs and warnings from CEO regarding my husband's performance insinuating that it is insufficient which put him on edge. I would consider this to be motivating by fear. None of these warnings are formally documented. He is also made aware that other management-level employees make as much or more than he does for a fraction of the work hours.

    4.) Random "black-outs" on vacations. I am currently in Louisiana with my husband for a work trip. We drove out so we could take a vacation road-trip our way back, but since my husband was told to fix problems that developed, our vacation was cancelled (spelling?) and he was told he would not be permitted to request vacation until after June because CEO and another manager just put in for vacations during the next few months. It occurs to me that it might be permitted in a small company, but it just feels wrong.

    I don't know what to do. My husband was diagnosed in September with an enlarged heart due to stress (per his new cardiologist) and has a history of high blood pressure. I KNOW it's because of this job (again, per his cardiologist) but I cannot convince him to confront the CEO about his work conditions. I feel that if I present my case in legal terms to the CEO, he will have no choice but to back off my husband without endangering our income and livelihood. I would also like to leave my husband out of it completely if at all possible. I can handle the FDA regulations side, but not the legal side and I cannot afford a lawyer. And frankly most of my information is probably considered hearsay because I am getting it through my husband. I am also afraid that my previous employment can make my actions seem retaliatory, even though I was fired in 2003.

    Also, I don't know if its relevant but we are not legally married. Maybe that limits my options.

    Any advice? I know this was long and I'm hoping what I wrote made sense. Thanks in advance.
    Last edited by angelabaca; 04-04-2013, 06:54 AM. Reason: clarification of facts

  • #2
    I'll let someone else respond to 1, but 2, 3, and 4 are not illegal. No law requires an employer to hire competent employees, no law requires an employer to be nice to his employees, and vacation scheduling is always at the discretion of the employer. It's clear that this is not an optimal situation, but the best thing that your husband can do may be to start looking for employment elsewhere.

    But, what I most want to tell you is that you have no dog in this fight. If you're husband is not willing to speak up at work, your going behind is back is not going to help the situation at all and could end up making things worse.
    I am not able to respond to private messages. Thanks!

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